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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 K910510
Device Name VALLEY FORGE BIPOLAR PEN OR FORCEPS
Applicant
Valley Forge Scientific Corp.
P.O. Box 925
Valley Forge,  PA  19482
Applicant Contact JERRY L MALIS
Correspondent
Valley Forge Scientific Corp.
P.O. Box 925
Valley Forge,  PA  19482
Correspondent Contact JERRY L MALIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/05/1991
Decision Date 04/22/1991
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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