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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps
510(k) Number K974593
Device Name SEMKIN INSULATED BIPOLAR FORCEP
Applicant
Titan Mfg., Inc.
6 Jamie Ln.
Phoenixville,  PA  19460
Applicant Contact DONALD SEAVEY
Correspondent
Titan Mfg., Inc.
6 Jamie Ln.
Phoenixville,  PA  19460
Correspondent Contact DONALD SEAVEY
Regulation Number878.4800
Classification Product Code
HTD  
Subsequent Product Code
GEI  
Date Received12/09/1997
Decision Date 06/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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