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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, polyester
510(k) Number K913101
Device Name PETERS CARDIOFLON(TM) SUTURE
Applicant
PROMEDICA PRODUCTS, INC.
620 NEWPORT CENTER DR.,
SUITE 575
NEWPORT BEACH,  CA  92660
Applicant Contact LEE HAND
Correspondent
PROMEDICA PRODUCTS, INC.
620 NEWPORT CENTER DR.,
SUITE 575
NEWPORT BEACH,  CA  92660
Correspondent Contact LEE HAND
Regulation Number878.5000
Classification Product Code
GAS  
Date Received07/12/1991
Decision Date 08/12/1992
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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