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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: SUPPLEMENTARY INFORMATION

USP , . ()
Address of Standards 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:
Processes Affected:
Type of Standard:
 National, Vertical
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§878.4493 Suture, Absorbable, Synthetic, Polyglycolic Acid Class 2 GAM
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§878.4830 Suture, Absorbable Class 2 GAK
§878.4830 Suture, Absorbable, Natural Class 2 GAL
 
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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