The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Minilap System With Minigrip Handle, Minilap System With Thumbgrip Handle.
| Device ID | K172775 |
| 510k Number | K172775 |
| Device Name: | MiniLap System With MiniGrip Handle, MiniLap System With ThumbGrip Handle |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Holly Hallock |
| Correspondent | Holly Hallock Teleflex Medical, Inc. 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-14 |
| Decision Date | 2018-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704630395 | K172775 | 000 |
| 44026704582608 | K172775 | 000 |
| 24026704640083 | K172775 | 000 |