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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Barrier, Protective
510(k) Number K944198
Device Name SURGICAL MICROSCOPE DRAPE
Applicant
Hydro-Med Products, Inc.
2930 Ladybird Ln.
Dallas,  TX  75220
Applicant Contact MATTHEW M HULL
Correspondent
Hydro-Med Products, Inc.
2930 Ladybird Ln.
Dallas,  TX  75220
Correspondent Contact MATTHEW M HULL
Regulation Number878.4370
Classification Product Code
MMP  
Date Received08/29/1994
Decision Date 11/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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