The following data is part of a premarket notification filed by Preservation Solutions, Inc. with the FDA for Clear-it Anti-fog, Model Ps003.
Device ID | K022826 |
510k Number | K022826 |
Device Name: | CLEAR-IT ANTI-FOG, MODEL PS003 |
Classification | Anti Fog Solution And Accessories, Endoscopy |
Applicant | PRESERVATION SOLUTIONS, INC. 8300 W. 110TH ST. Bloomington, MN 55438 |
Contact | John R Dalpee |
Correspondent | John R Dalpee PRESERVATION SOLUTIONS, INC. 8300 W. 110TH ST. Bloomington, MN 55438 |
Product Code | OCT |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-26 |
Decision Date | 2002-10-09 |
Summary: | summary |