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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameREPRO-MED - THD
Classification Namedevice, testicular hypothermia
Generic Nametesticular hypothermia device
ApplicantREPRO-MED SYSTEMS, INC.
PMA NumberP820034
Supplement NumberS002
Date Received02/04/1985
Decision Date05/12/1987
Product Code
LOA[ Registered Establishments with LOA ]
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
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