FDA 510(k) Application Details - K971986

Device Classification Name Electrocautery, Gynecologic (And Accessories)

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510(K) Number K971986
Device Name Electrocautery, Gynecologic (And Accessories)
Applicant VALLEY FORGE SCIENTIFIC CORP.
136 GREEN TREE RD.
P.O. BOX 1179
OAKS, PA 19456 US
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Contact JERRY L MALIS
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Regulation Number 884.4120

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Classification Product Code HGI
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Date Received 05/29/1997
Decision Date 08/26/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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