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510(k) K802001

LAP SPONGES CAT.#801-850 by Pollak (Intl.), Ltd. — Product Code KKX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 16, 1980
Date Received: August 20, 1980
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Drape, Surgical, Antimicrobial
Device Class: Class II
Regulation Number: 878.4370
Review Panel: HO
Submission Type

Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.

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)
K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)
K802013 — FIRST AID BANDAGE CAT.#198 OR 199 (September 16, 1980)
K801991 — PLASTIC FORCEPS CAT.#1001-1010 (September 16, 1980)
K802022 — STERILE GUAZE SWABS CAT.#301-420 (September 16, 1980)

Other clearances for product code KKX

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
K200238 — ControlRad Sterile Cover (April 26, 2020)
K163556 — MediClear PreOp (September 14, 2017)
K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
K140195 — SURGICAL DRAPE (September 10, 2014)
K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)