The following data is part of a premarket notification filed by Neo Metrics, Inc. with the FDA for Neowire Pta/ptca Guidewire.
| Device ID | K101729 |
| 510k Number | K101729 |
| Device Name: | NEOWIRE PTA/PTCA GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | NEO METRICS, INC. 2605 FERNBROOK LANE NORTH SUITE J Plymouth, MN 55447 |
| Contact | Gene Champeau |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-21 |
| Decision Date | 2010-09-23 |
| Summary: | summary |