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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received05/28/1982
Decision Date12/26/1984
Product Code
LOA[ Registered Establishments with LOA ]
Docket Number 85M-0007
Notice Date 01/25/1985
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 
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