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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K964143
Device Name MINI-SYMM BIPOLAR COAGULATOR
Applicant
Valley Forge Scientific Corp.
136 Green Tree Rd.
P.O. Box 1179
Oaks,  PA  19456
Applicant Contact JERRY L MALIS
Correspondent
Valley Forge Scientific Corp.
136 Green Tree Rd.
P.O. Box 1179
Oaks,  PA  19456
Correspondent Contact JERRY L MALIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/17/1996
Decision Date 01/09/1997
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
Predetermined Change
Control Plan Authorized
No
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