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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 6-328: USP 37-NF32:2014, nonabsorbable surgical suture. (General Plastic Surgery/General Hospital)

Date of Standard: 2014. 
Address of Standards Development Organization:
 United States Pharmacopeial Convention, Inc. (USP)
  12601 Twinbrook Parkway
  Rockville, MD 20852
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Nonabsorbable Surgical Sutures
Processes Affected:
510(k), IDE, PMA
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Suture, Nonabsorbable   GAO
§878.4495 Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile Class 2 GAQ
§878.5000 Suture, Nonabsorbable, Synthetic, Polyester Class 2 GAS
§878.5000 Suture, Nonabsorbable, Synthetic, Polyethylene Class 2 GAT
§878.5010 Suture, Nonabsorbable, Synthetic, Polypropylene Class 2 GAW
§878.5020 Suture, Nonabsorbable, Synthetic, Polyamide Class 2 GAR
§878.5030 Suture, Nonabsorbable, Silk Class 2 GAP
§878.5035 Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene Class 2 NBY
Relevant Guidance:
Guidance for Industry and FDA Staff-Class II Special Controls Guidance Document: Surgical Sutures: Guidance for Industry and FDA. Issued June 3, 2003
FDA Technical Contact:
 Maegen Colehour
  FDA/CDRH/ODE
  10903 New Hampshire Building 66, Room G423
  Silver Spring MD 20993
  301/796-6436
  email: maegen.colehour@fda.hhs.gov
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