EYE PADS CAT.#581-599— 510(k) K801995

Substantially Equivalent

Pollak (Intl.), Ltd.

FDA 510(k) clearance K801995 for EYE PADS CAT.#581-599, Substantially Equivalent on 1980-09-09. Applicant: Pollak (Intl.), Ltd.. Device class: 1.

Clearance details

Applicant: Pollak (Intl.), Ltd.
Product code: Code HMP
Device class: Class 1
Regulation: 21 CFR 878.4440
Advisory panel: General, Plastic Surgery
Date received: 1980-08-20
Decision date: 1980-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HMP

K940333 — EYE PAD1994-03-07
K921349 — STERILE,DISPOSABLE EYE DRESSING1992-05-29
K904896 — EYE PAD1990-12-05
K883822 — FIRST AID KIT, EYE DRESSING NSN6545-00-853-63091988-11-22
K874411 — DONALDSON NATURAL EYEPATCH 'PATIENT PAK'1988-01-27

More clearances from Pollak (Intl.), Ltd.

K000227 — UMBICUT2000-04-27
K810049 — PEDICAT*1981-04-21
K810050 — VECAFIX*1981-03-26
K802009 — FLOWCLAMP CAT.#1011 & 10121980-10-31
K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#11181980-10-31

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