ZOLLER BURNED LIP CONFORMER

Retractor, All Types

UNIVERSAL PROSTHETICS, INC.

The following data is part of a premarket notification filed by Universal Prosthetics, Inc. with the FDA for Zoller Burned Lip Conformer.

Pre-market Notification Details

Device IDK832366
510k NumberK832366
Device Name:ZOLLER BURNED LIP CONFORMER
ClassificationRetractor, All Types
Applicant UNIVERSAL PROSTHETICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEIG  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-18
Decision Date1983-09-26

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