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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical
510(k) Number K973554
Device Name VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
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
JOS  
Date Received09/19/1997
Decision Date 12/19/1997
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
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