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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
Predetermined Change
Control Plan Authorized		 No
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