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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 K863376
Device Name MODEL MC-1 SURGICAL VIDEO CAMERA
Applicant
Biometric Products, Inc.
4275a SW 73rd Ave.
Miami,  FL  33155
Applicant Contact KATCHIS, JR
Correspondent
Biometric Products, Inc.
4275a SW 73rd Ave.
Miami,  FL  33155
Correspondent Contact KATCHIS, JR
Regulation Number878.4160
Classification Product Code
FWF  
Date Received09/03/1986
Decision Date 10/02/1986
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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