The following data is part of a premarket notification filed by Advanced Surgical Concepts (asc) with the FDA for Space-or Retractor.
| Device ID | K993544 |
| 510k Number | K993544 |
| Device Name: | SPACE-OR RETRACTOR |
| Classification | Retractor, Self-retaining |
| Applicant | ADVANCED SURGICAL CONCEPTS (ASC) 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara Cullinane |
| Correspondent | Mary Mcnamara Cullinane ADVANCED SURGICAL CONCEPTS (ASC) 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FFO |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-19 |
| Decision Date | 1999-12-22 |
| Summary: | summary |