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510(k) K802009

FLOWCLAMP CAT.#1011 & 1012 by Pollak (Intl.), Ltd. — Product Code FKK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1980
Date Received
August 20, 1980
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 Pollak (Intl.), Ltd.

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  • K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 (October 31, 1980)
  • K802017 — DRESSING CHANGE SET CAT.#910-930 (October 10, 1980)
  • K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)
  • K801996 — GUAZE BANDAGES CAT.#101-169 (September 16, 1980)
  • K802004 — PROFILE SWAB CAT.#5273 & 5274 (September 16, 1980)
  • K802021 — PEDIBAND CAT.#195-197 (September 16, 1980)
  • K802016 — EYE APPLICATORS CAT.#980-983 (September 16, 1980)

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)
  • K822551 — AMP CAPD UNISPIKE AMINISTRATION SET (October 13, 1982)