The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Wound Protector/retractor.
| Device ID | K020435 |
| 510k Number | K020435 |
| Device Name: | WOUND PROTECTOR/RETRACTOR |
| Classification | Drape, Surgical |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Anil Bhalani |
| Correspondent | Anil Bhalani APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-08 |
| Decision Date | 2002-04-15 |
| Summary: | summary |