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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K940151
Device Name ULTRASOUND PROBE DRAPE
Applicant
Hydro-Med Products, Inc.
2930 Ladybird Ln.
Dallas,  TX  75220
Applicant Contact BONNIE BEASLEY
Correspondent
Hydro-Med Products, Inc.
2930 Ladybird Ln.
Dallas,  TX  75220
Correspondent Contact BONNIE BEASLEY
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/03/1994
Decision Date 11/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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