The following data is part of a premarket notification filed by Avail-southwest Division with the FDA for Sta-clear Alcohol-free Endoscopic Anti-fog Kit.
| Device ID | K952678 |
| 510k Number | K952678 |
| Device Name: | STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT |
| Classification | Chisel (osteotome) |
| Applicant | AVAIL-SOUTHWEST DIVISION 13737 STEMMONS FREEWAY Dallas, TX 75234 |
| Contact | Angel R Diaz |
| Correspondent | Angel R Diaz AVAIL-SOUTHWEST DIVISION 13737 STEMMONS FREEWAY Dallas, TX 75234 |
| Product Code | KDG |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1995-07-10 |