The following data is part of a premarket notification filed by Cox Medical Ent., Inc. with the FDA for Basics Endoscopy System.
| Device ID | K941464 |
| 510k Number | K941464 |
| Device Name: | BASICS ENDOSCOPY SYSTEM |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | COX MEDICAL ENT., INC. 2186 EASTMAN AVE. SUITE 110 Ventura, CA 93003 |
| Contact | Lanita Cox |
| Correspondent | Lanita Cox COX MEDICAL ENT., INC. 2186 EASTMAN AVE. SUITE 110 Ventura, CA 93003 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-28 |
| Decision Date | 1994-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10350770927692 | K941464 | 000 |
| 10350770926534 | K941464 | 000 |
| 30680651926600 | K941464 | 000 |
| 30680651926594 | K941464 | 000 |
| 30680651926587 | K941464 | 000 |
| 30680651926570 | K941464 | 000 |
| 30680651926563 | K941464 | 000 |
| 30680651926556 | K941464 | 000 |
| 30680651926549 | K941464 | 000 |
| 10350770926541 | K941464 | 000 |
| 10350770926558 | K941464 | 000 |
| 10350770926565 | K941464 | 000 |
| 10350770927685 | K941464 | 000 |
| 10350770927678 | K941464 | 000 |
| 10350770927661 | K941464 | 000 |
| 10350770927654 | K941464 | 000 |
| 10350770926602 | K941464 | 000 |
| 10350770926596 | K941464 | 000 |
| 10350770926589 | K941464 | 000 |
| 10350770926572 | K941464 | 000 |
| 30680651926532 | K941464 | 000 |