The following data is part of a premarket notification filed by Advanced Surgical Concepts (asc) with the FDA for Ecotract Adjustable Wound Protector/retractor.
| Device ID | K010711 |
| 510k Number | K010711 |
| Device Name: | ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR |
| Classification | Drape, Surgical |
| 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-09 |
| Decision Date | 2001-05-22 |