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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, polyglycolic acid
510(k) Number K043539
Device Name DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
Applicant
DEMETECH CORP.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
DEMETECH CORP.
962 ALLEGRO LANE
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number878.4493
Classification Product Code
GAM  
Date Received12/22/2004
Decision Date 04/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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