TRIANGULAR BANDAGE CAT.#191

Dressing, Wound, Drug

POLLAK (INTL.), LTD.

The following data is part of a premarket notification filed by Pollak (intl.), Ltd. with the FDA for Triangular Bandage Cat.#191.

Pre-market Notification Details

Device IDK802006
510k NumberK802006
Device Name:TRIANGULAR BANDAGE CAT.#191
ClassificationDressing, Wound, Drug
Applicant POLLAK (INTL.), LTD. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-08-20
Decision Date1980-09-16

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