The following data is part of a premarket notification filed by Avail-southwest Division with the FDA for Endoscopic Anti-fog Kit, 100-302-00.
| Device ID | K933520 |
| 510k Number | K933520 |
| Device Name: | ENDOSCOPIC ANTI-FOG KIT, 100-302-00 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | AVAIL-SOUTHWEST DIVISION 13737 STEMMONS FREEWAY Dallas, TX 75234 |
| Contact | Sharon D Cheatwood |
| Correspondent | Sharon D Cheatwood AVAIL-SOUTHWEST DIVISION 13737 STEMMONS FREEWAY Dallas, TX 75234 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-20 |
| Decision Date | 1993-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884527015900 | K933520 | 000 |
| 20884527015884 | K933520 | 000 |