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 |