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510(k) K823827

AMP 80/2 OUTFLOW MONITOR MODIFICATION by American Medical Products, Inc. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
December 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by American Medical Products, Inc.

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  • K830881 — AMPERCIDE DISINFECTANT ACCESSORY TO - (June 2, 1983)
  • K822544 — SAFE LOCK SEALING CAP L (October 13, 1982)
  • K822551 — AMP CAPD UNISPIKE AMINISTRATION SET (October 13, 1982)
  • K822546 — SAFE LOCK SEALING CAPS (October 13, 1982)
  • K822543 — CAPD SAFE LOCK TRANSFER SET (October 13, 1982)
  • K822550 — SAFE LOCK TITANIUM ADAPTER SET (October 13, 1982)
  • K822549 — CCPD CYCLER SET W/5 PRONGED SAFE LOCK (October 13, 1982)

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