The following data is part of a premarket notification filed by National Reading Service with the FDA for Plastic Overlays.
Device ID | K911374 |
510k Number | K911374 |
Device Name: | PLASTIC OVERLAYS |
Classification | Prism, Bar, Ophthalmic |
Applicant | NATIONAL READING SERVICE 2104 S.W. ADAMS ST. PEORIA, IL 61602 |
Contact | SUMNER BORIN |
Correspondent | SUMNER BORIN NATIONAL READING SERVICE 2104 S.W. ADAMS ST. PEORIA, IL 61602 |
Product Code | HKW |
CFR Regulation Number | 886.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-28 |
Decision Date | 1991-07-26 |