The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Gelpoint Path.
| Device ID | K110792 |
| 510k Number | K110792 |
| Device Name: | GELPOINT PATH |
| Classification | Anoscope And Accessories |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Frans Vandenbroek |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-21 |
| Decision Date | 2011-05-23 |
| Summary: | summary |