The following data is part of a premarket notification filed by Medcomp with the FDA for Micro-stick Set.
| Device ID | K091954 |
| 510k Number | K091954 |
| Device Name: | MICRO-STICK SET |
| Classification | Introducer, Catheter |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Susan Pileggi |
| Correspondent | Susan Pileggi MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2010-01-08 |
| Summary: | summary |