The following data is part of a premarket notification filed by Michael A Clark with the FDA for Endoxflex 5000.
| Device ID | K946239 |
| 510k Number | K946239 |
| Device Name: | ENDOXFLEX 5000 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICHAEL A CLARK 1070 THORNWOOD LN. Dacula, GA 30211 -3007 |
| Contact | Michael A Clark |
| Correspondent | Michael A Clark MICHAEL A CLARK 1070 THORNWOOD LN. Dacula, GA 30211 -3007 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-22 |
| Decision Date | 1995-01-30 |