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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K950745
Device Name CHAKOFF ENDOSCOPY (ENDOSCOPE AND/OR ACCESSORIES)
Applicant
STEPHEN CHAKOFF, INC.
15405 SOUTHWEST 72 CT.
MIAMI,  FL  33157
Applicant Contact FRANK GOLDFARB
Correspondent
STEPHEN CHAKOFF, INC.
15405 SOUTHWEST 72 CT.
MIAMI,  FL  33157
Correspondent Contact FRANK GOLDFARB
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
FCW   FST   GCT   GEI  
Date Received02/17/1995
Decision Date 03/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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