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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter (gastric, colonic, etc.), irrigation and aspiration
510(k) Number K911919
Device Name MINIVAGE(R)
Applicant
AUTOVAGE
1631 CITATION DR.
SOUTH PARK,  PA  15129
Applicant Contact JOSEPH P RUDOLPH
Correspondent
AUTOVAGE
1631 CITATION DR.
SOUTH PARK,  PA  15129
Correspondent Contact JOSEPH P RUDOLPH
Regulation Number876.5980
Classification Product Code
KDH  
Date Received04/30/1991
Decision Date 07/26/1991
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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