The following data is part of a premarket notification filed by Microline Surgical, Inc. with the FDA for M/l-10 Clip Applier Sterilization Tray (catalog#3706).
| Device ID | K152743 |
| 510k Number | K152743 |
| Device Name: | M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706) |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | MICROLINE SURGICAL, INC. 50 DUNHAM ROAD SUITE 1500 Beverly, MA 01915 |
| Contact | Anu Gaur |
| Correspondent | Anu Gaur MICROLINE SURGICAL, INC. 50 DUNHAM ROAD SUITE 1500 Beverly, MA 01915 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-23 |
| Decision Date | 2016-02-08 |
| Summary: | summary |