The following data is part of a premarket notification filed by Maurry Biological Co. with the FDA for Wetting Solution For Hard Contact Lenses.
Device ID | K853810 |
510k Number | K853810 |
Device Name: | WETTING SOLUTION FOR HARD CONTACT LENSES |
Classification | Lens, Contact (polymethylmethacrylate) |
Applicant | MAURRY BIOLOGICAL CO. 6109 SOUTH WESTERN AVE. Los Angeles, CA 90047 |
Contact | Des Rochers |
Correspondent | Des Rochers MAURRY BIOLOGICAL CO. 6109 SOUTH WESTERN AVE. Los Angeles, CA 90047 |
Product Code | HPX |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-11 |
Decision Date | 1985-12-16 |