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510(k) K831689

EMPTY DIALYSATE CONTAINER by Delmed, Inc. — Product Code FKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1983
Date Received
May 24, 1983
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

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  • K895919 — ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III (May 2, 1990)
  • K895933 — ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III (May 2, 1990)
  • K895246 — FRENTA(R) DUO-SET (May 2, 1990)

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)
  • K822551 — AMP CAPD UNISPIKE AMINISTRATION SET (October 13, 1982)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)