The following data is part of a premarket notification filed by Tucson Medical Corp. with the FDA for Clearfield Anti-fog Sterile Wipe, Product Number 300-004.
| Device ID | K974454 |
| 510k Number | K974454 |
| Device Name: | CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | TUCSON MEDICAL CORP. 3941 EAST 29TH ST., SUITE 601 Tucson, AZ 85711 |
| Contact | Jim Patko |
| Correspondent | Jim Patko TUCSON MEDICAL CORP. 3941 EAST 29TH ST., SUITE 601 Tucson, AZ 85711 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1997-12-18 |
| Summary: | summary |