The following data is part of a premarket notification filed by Duopross Meditech Corporation with the FDA for Duopross Needle.
| Device ID | K052445 |
| 510k Number | K052445 |
| Device Name: | DUOPROSS NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | DUOPROSS MEDITECH CORPORATION 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson DUOPROSS MEDITECH CORPORATION 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-07 |
| Decision Date | 2005-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784693231 | K052445 | 000 |
| 00616784693132 | K052445 | 000 |