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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 K822546
Device Name SAFE LOCK SEALING CAPS
Applicant
AMERICAN MEDICAL PRODUCTS, INC.
P.O. DRAWER 190
FREEHOLD,  NJ  07728
Applicant Contact JOSEPH J BUTLER
Correspondent
AMERICAN MEDICAL PRODUCTS, INC.
P.O. DRAWER 190
FREEHOLD,  NJ  07728
Correspondent Contact JOSEPH J BUTLER
Regulation Number876.5630
Classification Product Code
FKX  
Date Received08/24/1982
Decision Date 10/13/1982
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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