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U.S. Department of Health and Human Services

Recognized Consensus Standards

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FR Publication Date: 01/30/2014 

Part B: Supplementary Information

USP 32:2009, absorbable surgical suture. (General Plastic Surgery/General Hospital)
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:
Absorbable 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
§878.4493 Suture, Absorbable, Synthetic, Polyglycolic Acid Class 2 GAM
§878.4830 Suture, Absorbable Class 2 GAK
§878.4830 Suture, Absorbable, Natural Class 2 GAL
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:
 George Mattamal
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1434
  Silver Spring MD 20993
  301/796-6396
  email: george.mattamal@fda.hhs.gov
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