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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K932632
Device Name CHAKOFF ENDOSCOPY LAPAROSCOPIC INSTRUMENTATION
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 Number878.4400
Classification Product Code
GEI  
Date Received06/01/1993
Decision Date 06/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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