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 |