The following data is part of a premarket notification filed by Injectimed, Inc. with the FDA for Frontline Medical Safetynet Guidewire Introducer.
| Device ID | K073664 |
| 510k Number | K073664 |
| Device Name: | FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | INJECTIMED, INC. 5616 MARIOLA PL NE Albuquerque, NM 87111 |
| Contact | Richard G Hunter |
| Correspondent | Richard G Hunter INJECTIMED, INC. 5616 MARIOLA PL NE Albuquerque, NM 87111 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-08-08 |
| Summary: | summary |