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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Television, Endoscopic, Without Audio
510(k) Number K932628
Device Name ENDOSCOPIC VIDEO CAMERA
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 Number878.4160
Classification Product Code
FWF  
Date Received06/01/1993
Decision Date 10/15/1993
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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