The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Laparoscopic Dissector.
| Device ID | K103282 |
| 510k Number | K103282 |
| Device Name: | LAPAROSCOPIC DISSECTOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Frans Vandenbroek |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-05 |
| Decision Date | 2010-11-16 |
| Summary: | summary |