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 |