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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 K900198
Device Name DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
Applicant
AMERICAN CYANAMID CO.
ONE CASPER ST.
DANBURY,  CT  06810
Applicant Contact ROBERT I PELLETIER
Correspondent
AMERICAN CYANAMID CO.
ONE CASPER ST.
DANBURY,  CT  06810
Correspondent Contact ROBERT I PELLETIER
Regulation Number878.4830
Classification Product Code
GAN  
Date Received01/16/1990
Decision Date 07/05/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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