The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Schwartz/norris Corneal Light Shield.
Device ID | K844761 |
510k Number | K844761 |
Device Name: | SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD |
Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Contact | William T George |
Correspondent | William T George MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Product Code | HOY |
CFR Regulation Number | 886.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-07 |
Decision Date | 1984-12-24 |