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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 K823827
Device Name AMP 80/2 OUTFLOW MONITOR MODIFICATION
Applicant
American Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Medical Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5630
Classification Product Code
FKX  
Date Received12/20/1982
Decision Date 03/17/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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