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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 K930053
Device Name VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10
Applicant
Medical Devices, Inc.
83 Hobart St.
Hackensack,  NJ  07601
Applicant Contact SAMUEL DICKSTEIN
Correspondent
Medical Devices, Inc.
83 Hobart St.
Hackensack,  NJ  07601
Correspondent Contact SAMUEL DICKSTEIN
Regulation Number878.4160
Classification Product Code
FWF  
Date Received01/06/1993
Decision Date 05/17/1993
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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