The following data is part of a premarket notification filed by Rainbow Optics, Inc. with the FDA for Frames, Spectacle.
Device ID | K932813 |
510k Number | K932813 |
Device Name: | FRAMES, SPECTACLE |
Classification | Frame, Spectacle |
Applicant | RAINBOW OPTICS, INC. 2 NE 40TH ST. P.O. BOX 379010 Miami, FL 33137 -9010 |
Contact | Perry Popkin |
Correspondent | Perry Popkin RAINBOW OPTICS, INC. 2 NE 40TH ST. P.O. BOX 379010 Miami, FL 33137 -9010 |
Product Code | HQZ |
CFR Regulation Number | 886.5842 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-09 |
Decision Date | 1993-08-31 |