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510(k) K811986

THE AMP 80/2 PEDIATRIC CYCLER SYSTEM by American Medical Products, Inc. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
July 13, 1981
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.

  • K922290 — SINGLE-STEP PREGNANCY, HCG TEST (July 9, 1992)
  • K862221 — E-Z CLEAN (September 12, 1986)
  • K861251 — AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N (April 17, 1986)
  • K830881 — AMPERCIDE DISINFECTANT ACCESSORY TO - (June 2, 1983)
  • K823827 — AMP 80/2 OUTFLOW MONITOR MODIFICATION (March 17, 1983)
  • K822543 — CAPD SAFE LOCK TRANSFER SET (October 13, 1982)
  • K822550 — SAFE LOCK TITANIUM ADAPTER SET (October 13, 1982)
  • K822546 — SAFE LOCK SEALING CAPS (October 13, 1982)
  • K822549 — CCPD CYCLER SET W/5 PRONGED SAFE LOCK (October 13, 1982)
  • K822544 — SAFE LOCK SEALING CAP L (October 13, 1982)

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  • K171652 — Fresenius Liberty Select Cycler (September 15, 2017)