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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 Doppler, Ultrasonic
510(k) Number K951695
Device Name OPERAND* ULTRASOUND TRANSMISSION GEL
Applicant
Redi Products, Inc.
Prichard Industrial Park
P.O. Box 237
Prichard,  WV  25555
Applicant Contact JOSEPH LANGDON
Correspondent
Redi Products, Inc.
Prichard Industrial Park
P.O. Box 237
Prichard,  WV  25555
Correspondent Contact JOSEPH LANGDON
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received04/12/1995
Decision Date 05/12/1995
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
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