The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Applied Laparoscopic Disposable Monopolar Scissors.
| Device ID | K062169 |
| 510k Number | K062169 |
| Device Name: | APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Cheryl Blake |
| Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-08-24 |
| Summary: | summary |