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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Peritoneal, Automatic Delivery
510(k) Number K823857
Device Name IMPRA PERITONEAL CATHETER
Applicant
IMPRA, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
IMPRA, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5630
Classification Product Code
FKX  
Date Received12/22/1982
Decision Date 01/26/1983
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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