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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, Surgical, With Audio
510(k) Number K890119
Device Name BR-S601MU (SURGICAL VIDEO RECORDER)
Applicant
Victor Co. of Japan, Ltd. C/O Jvc Corp.
41 Slater Dr.
Elmwood Park,  NJ  07407
Applicant Contact TED MARKS
Correspondent
Victor Co. of Japan, Ltd. C/O Jvc Corp.
41 Slater Dr.
Elmwood Park,  NJ  07407
Correspondent Contact TED MARKS
Regulation Number878.4160
Classification Product Code
FWC  
Date Received01/11/1989
Decision Date 01/24/1989
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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