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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
Other 510(k) Applications for this Contact
Regulation Number
884.4120
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Classification Product Code
HGI
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More FDA Info for this Product Code
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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