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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Surgical And Accessories
510(k) Number K812405
Device Name STERILE TV CAMERA & CORD COVER
Applicant
HYDRO-MED PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HYDRO-MED PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4160
Classification Product Code
KQM  
Date Received08/21/1981
Decision Date 10/20/1981
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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