The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Alexis Orthopaedic Wound Retractor.
| Device ID | K100120 |
| 510k Number | K100120 |
| Device Name: | ALEXIS ORTHOPAEDIC WOUND RETRACTOR |
| Classification | Ring (wound Protector), Drape Retention, Internal |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Frans Vandenbroek |
| Correspondent | Frans Vandenbroek APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | KGW |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-15 |
| Decision Date | 2010-04-02 |
| Summary: | summary |