The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Optical Separator.
| Device ID | K032889 |
| 510k Number | K032889 |
| Device Name: | OPTICAL SEPARATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Cheryl Blake |
| Correspondent | Ellen Fickewirth UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2003-10-02 |
| Summary: | summary |