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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, Synthetic, Polypropylene
510(k) Number K001625
Device Name PRONOVA NONABSORBABLE SUTURE, USP
Applicant
ETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville,  NJ  08876
Applicant Contact PETER M CECCHINI
Correspondent
ETHICON, Inc.
P.O Box 151, Rte. 22 W.
Somerville,  NJ  08876
Correspondent Contact PETER M CECCHINI
Regulation Number878.5010
Classification Product Code
GAW  
Date Received05/17/2000
Decision Date 07/10/2000
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
Predetermined Change
Control Plan Authorized		 No
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