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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Basket, Ureteral, Metal
510(k) Number K811580
Device Name GLASSMAN-DORMIA GALLSTONE EXTRACTOR SET
Applicant
PORGES CATHETER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PORGES CATHETER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.4680
Classification Product Code
FFL  
Date Received06/05/1981
Decision Date 06/26/1981
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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