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510(k) K802009

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

K802009 is an FDA 510(k) premarket notification submitted by Pollak (Intl.), Ltd. for the device "FLOWCLAMP CAT.#1011 & 1012". The FDA issued a decision of Substantially Equivalent on October 31, 1980. The device falls under product code FKK (Clamp, Line), a Class I device regulated under 21 CFR 876.4730. Pollak (Intl.), Ltd. has at least 10 other 510(k) clearances on record.

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.

  • K000227 — UMBICUT (April 27, 2000)
  • K810049 — PEDICAT* (April 21, 1981)
  • K810050 — VECAFIX* (March 26, 1981)
  • 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)
  • K802013 — FIRST AID BANDAGE CAT.#198 OR 199 (September 16, 1980)
  • K802022 — STERILE GUAZE SWABS CAT.#301-420 (September 16, 1980)
  • K801991 — PLASTIC FORCEPS CAT.#1001-1010 (September 16, 1980)
  • K802016 — EYE APPLICATORS CAT.#980-983 (September 16, 1980)

Other clearances for product code FKK

  • K854512 — TUBING CLAMP CAT#1000-A (December 2, 1985)
  • K854517 — NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (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)

FDA data resources