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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, external penile rigidity
510(k) Number K832756
Device Name PRI A PUS
Applicant
TRANS TEXAS MEDICAL DEVICES CORP.
561 METROPLITAN PROF. BLDG.
SAN ANTONIO,  TX  78212
Applicant Contact NADIG, M.D.
Correspondent
TRANS TEXAS MEDICAL DEVICES CORP.
561 METROPLITAN PROF. BLDG.
SAN ANTONIO,  TX  78212
Correspondent Contact NADIG, M.D.
Regulation Number876.5020
Classification Product Code
LKY  
Date Received08/16/1983
Decision Date 11/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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