The following data is part of a premarket notification filed by Universal Prosthetics, Inc. with the FDA for Zoller Burned Lip Conformer.
Device ID | K832366 |
510k Number | K832366 |
Device Name: | ZOLLER BURNED LIP CONFORMER |
Classification | Retractor, All Types |
Applicant | UNIVERSAL PROSTHETICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EIG |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-18 |
Decision Date | 1983-09-26 |