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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K961460
Device Name LWEET CONE BIOPSY INSTRUMENT
Applicant
APPLE MEDICAL CORP.
23 WEILSEWITZ RD.
RINGOES,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
APPLE MEDICAL CORP.
23 WEILSEWITZ RD.
RINGOES,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number884.4120
Classification Product Code
HGI  
Date Received04/16/1996
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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