The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Flexposure Retractor.
| Device ID | K983144 |
| 510k Number | K983144 |
| Device Name: | FLEXPOSURE RETRACTOR |
| Classification | Arthroscope |
| Applicant | ENDIUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane ENDIUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1999-02-24 |
| Summary: | summary |