The following data is part of a premarket notification filed by Miret Surgical Inc. with the FDA for Miret Grasper, Alligator, Miret Grasper, Maryland.
| Device ID | K160149 |
| 510k Number | K160149 |
| Device Name: | Miret Grasper, Alligator, Miret Grasper, Maryland |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | MIRET SURGICAL INC. 205 E. BUTTERFIELD ROAD, SUITE 457 Elmhurst, IL 60126 |
| Contact | Avi Roop |
| Correspondent | Jerzy Wojcik EDGEONE MEDICAL 455 N CAMPBELL AVE, #2N Chicago, IL 60612 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-21 |
| Decision Date | 2016-08-30 |
| Summary: | summary |