The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Universal Eye Shield.
Device ID | K841599 |
510k Number | K841599 |
Device Name: | STORZ UNIVERSAL EYE SHIELD |
Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
Applicant | STORZ INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HOY |
CFR Regulation Number | 886.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-18 |
Decision Date | 1984-05-22 |