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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, absorbable, synthetic
510(k) Number K951231
Device Name ORTHOPEDIC PACKS
Applicant
STERILE CONCEPTS, INC.
5100 COMMERCE RD..
RICHMOND,  VA  23234
Applicant Contact DARREN REEVES
Correspondent
STERILE CONCEPTS, INC.
5100 COMMERCE RD..
RICHMOND,  VA  23234
Correspondent Contact DARREN REEVES
Regulation Number878.4830
Classification Product Code
GAN  
Date Received03/20/1995
Decision Date 12/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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