The following data is part of a premarket notification filed by Aukland Medical Plastics, Inc. with the FDA for Post-myds(tm).
Device ID | K930840 |
510k Number | K930840 |
Device Name: | POST-MYDS(TM) |
Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
Applicant | AUKLAND MEDICAL PLASTICS, INC. P.O. BOX 5624 Cary, NC 27512 |
Contact | Norman A Gray |
Correspondent | Norman A Gray AUKLAND MEDICAL PLASTICS, INC. P.O. BOX 5624 Cary, NC 27512 |
Product Code | HOY |
CFR Regulation Number | 886.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-17 |
Decision Date | 1994-03-01 |