FDA 510(k) Application Details - K961460

Device Classification Name Electrocautery, Gynecologic (And Accessories)

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510(K) Number K961460
Device Name Electrocautery, Gynecologic (And Accessories)
Applicant APPLE MEDICAL CORP.
23 WEILSEWITZ RD.
RINGOES, NJ 08551 US
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Contact RANDOLPH L COOKE
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Regulation Number 884.4120

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Classification Product Code HGI
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Date Received 04/16/1996
Decision Date 11/19/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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