The following data is part of a premarket notification filed by Duopross Meditech Corporation with the FDA for Duopross Syringes.
Device ID | K042500 |
510k Number | K042500 |
Device Name: | DUOPROSS SYRINGES |
Classification | Syringe, Piston |
Applicant | DUOPROSS MEDITECH CORPORATION 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
Contact | Frank Freguson |
Correspondent | Frank Freguson DUOPROSS MEDITECH CORPORATION 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-09-14 |
Decision Date | 2005-02-22 |
Summary: | summary |