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510(k) K802007

PEDIWET=GUAZE IMPREGNATED WITH PETROL by Pollak (Intl.), Ltd. — Product Code FRQ

K802007 is an FDA 510(k) premarket notification submitted by Pollak (Intl.), Ltd. for the device "PEDIWET=GUAZE IMPREGNATED WITH PETROL". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code FRQ (Tube, Levine), a Class II device regulated under 21 CFR 876.5980. Pollak (Intl.), Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Levine
Device Class
Class II
Regulation Number
876.5980
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)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)
  • K802017 — DRESSING CHANGE SET CAT.#910-930 (October 10, 1980)
  • K802016 — EYE APPLICATORS CAT.#980-983 (September 16, 1980)
  • K802013 — FIRST AID BANDAGE CAT.#198 OR 199 (September 16, 1980)
  • K801991 — PLASTIC FORCEPS CAT.#1001-1010 (September 16, 1980)
  • K802001 — LAP SPONGES CAT.#801-850 (September 16, 1980)

Other clearances for product code FRQ

  • K914887 — ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT (May 8, 1992)
  • K914530 — ICAN GT DRAINAGE BAG (December 18, 1991)

FDA data resources