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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 K854988
Device Name KY-M280U SURGICAL CAMERA
Applicant
US JVC CORP.
41 SLATER DR.
ELMWOOD PARK,  NJ  07407
Applicant Contact TED MARKS
Correspondent
US JVC CORP.
41 SLATER DR.
ELMWOOD PARK,  NJ  07407
Correspondent Contact TED MARKS
Regulation Number878.4160
Classification Product Code
FWC  
Date Received12/12/1985
Decision Date 01/24/1986
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
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