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510(k) K822551

AMP CAPD UNISPIKE AMINISTRATION SET by American Medical Products, Inc. — Product Code FKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1982
Date Received
August 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Line
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by American Medical Products, Inc.

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  • 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)

Other clearances for product code FKK

  • K854517 — NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (December 2, 1985)
  • K854512 — TUBING CLAMP CAT#1000-A (December 2, 1985)
  • K844121 — CLAMP, TUBING, LINE (December 17, 1984)
  • K831689 — EMPTY DIALYSATE CONTAINER (August 11, 1983)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)