The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Gelpoint Path Transanal Access Platform.
| Device ID | K133393 |
| 510k Number | K133393 |
| Device Name: | GELPOINT PATH TRANSANAL ACCESS PLATFORM |
| Classification | Anoscope And Accessories |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Frans Vandenbroek |
| Correspondent | Frans Vandenbroek APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-05 |
| Decision Date | 2014-01-02 |
| Summary: | summary |