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510(k) K802017

DRESSING CHANGE SET CAT.#910-930 by Pollak (Intl.), Ltd. — Product Code KDD

K802017 is an FDA 510(k) premarket notification submitted by Pollak (Intl.), Ltd. for the device "DRESSING CHANGE SET CAT.#910-930". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Pollak (Intl.), Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
August 20, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Pollak (Intl.), Ltd.

  • K000227 — UMBICUT (April 27, 2000)
  • K810049 — PEDICAT* (April 21, 1981)
  • K810050 — VECAFIX* (March 26, 1981)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)
  • K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 (October 31, 1980)
  • K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)
  • K802013 — FIRST AID BANDAGE CAT.#198 OR 199 (September 16, 1980)
  • K802001 — LAP SPONGES CAT.#801-850 (September 16, 1980)
  • K802022 — STERILE GUAZE SWABS CAT.#301-420 (September 16, 1980)
  • K801991 — PLASTIC FORCEPS CAT.#1001-1010 (September 16, 1980)

Other clearances for product code KDD

  • K072814 — CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPA (April 16, 2008)
  • K011514 — INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (August 13, 2001)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K960456 — DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LIN (April 1, 1996)
  • K936255 — CUSTOM CV PACK (March 31, 1994)
  • K932219 — SUTURE SET OR LACERATION TRAYS (PACKS) (July 9, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K925905 — KIT, SURGICAL INSTRUMENT, DISPOSABLE (June 16, 1993)
  • K924958 — BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (June 7, 1993)
  • K925215 — STERILE SURGICAL INSTRUMENT TRAYS (June 1, 1993)

FDA data resources