The following data is part of a premarket notification filed by Sciara Intl., Inc. with the FDA for Spectacle Frame.
Device ID | K920170 |
510k Number | K920170 |
Device Name: | SPECTACLE FRAME |
Classification | Frame, Spectacle |
Applicant | SCIARA INTL., INC. 182-08 149TH AVE. Springfield Gardens, NY 11413 |
Contact | Marilyn Mahler |
Correspondent | Marilyn Mahler SCIARA INTL., INC. 182-08 149TH AVE. Springfield Gardens, NY 11413 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-13 |
Decision Date | 1992-03-11 |