The following data is part of a premarket notification filed by Altaire Pharmaceuticals, Inc. with the FDA for Altaire Mps#1 Multipurpose Contact Lens Solution.
Device ID | K062332 |
510k Number | K062332 |
Device Name: | ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION |
Classification | Accessories, Soft Lens Products |
Applicant | ALTAIRE PHARMACEUTICALS, INC. GRAND VALLEY BUSINESS PLAZA SUITE B7 Grand Junction, CO 81505 |
Contact | Martin Dalsing |
Correspondent | Martin Dalsing ALTAIRE PHARMACEUTICALS, INC. GRAND VALLEY BUSINESS PLAZA SUITE B7 Grand Junction, CO 81505 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-10 |
Decision Date | 2007-04-25 |
Summary: | summary |