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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
510(k) Number K930992
Device Name FLEXON AND STAINLESS STEEL SUTURES
Applicant
AMERICAN CYANAMID CO.
ONE CASPER ST.
DANBURY,  CT  06810
Applicant Contact JOHN F SCHAEFER
Correspondent
AMERICAN CYANAMID CO.
ONE CASPER ST.
DANBURY,  CT  06810
Correspondent Contact JOHN F SCHAEFER
Regulation Number878.4495
Classification Product Code
GAQ  
Date Received02/25/1993
Decision Date 12/17/1993
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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