The following data is part of a premarket notification filed by Zee Medical Products Co., Inc. with the FDA for Ultra-wide Safety Spectacle Frame.
Device ID | K813156 |
510k Number | K813156 |
Device Name: | ULTRA-WIDE SAFETY SPECTACLE FRAME |
Classification | Frame, Spectacle |
Applicant | ZEE MEDICAL PRODUCTS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-06 |
Decision Date | 1981-12-14 |