PEDICAT*— 510(k) K810049

Substantially Equivalent

Pollak (Intl.), Ltd.

FDA 510(k) clearance K810049 for PEDICAT*, Substantially Equivalent on 1981-04-21. Applicant: Pollak (Intl.), Ltd.. Device class: 1.

Clearance details

Applicant: Pollak (Intl.), Ltd.
Product code: Code KMJ
Device class: Class 1
Regulation: 21 CFR 880.6375
Advisory panel: General Hospital
Date received: 1981-01-13
Decision date: 1981-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMJ

K142473 — Lubricating Jelly2015-04-13
K141028 — COLONGLIDE LUBRICANT2014-07-24
K131617 — COLONGLIDE(R) LUBRICANT2013-10-03
K121390 — LUBE JELLY SURINGE2012-08-10
K113689 — DUKAL LUBRICATING JELLY2012-05-04

More clearances from Pollak (Intl.), Ltd.

K000227 — UMBICUT2000-04-27
K810050 — VECAFIX*1981-03-26
K802009 — FLOWCLAMP CAT.#1011 & 10121980-10-31
K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#11181980-10-31
K802017 — DRESSING CHANGE SET CAT.#910-9301980-10-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.