The following data is part of a premarket notification filed by Ultimed Incorporated with the FDA for Ulticare Safety Syringe With Removable Needle.
Device ID | K140949 |
510k Number | K140949 |
Device Name: | ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE |
Classification | Syringe, Antistick |
Applicant | ULTIMED INCORPORATED 5353 WAYZATA BLVD., SUITE 505 Minneapolis, MN 55416 |
Contact | Mary Beth Henderson |
Correspondent | Mary Beth Henderson ULTIMED INCORPORATED 5353 WAYZATA BLVD., SUITE 505 Minneapolis, MN 55416 |
Product Code | MEG |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-14 |
Decision Date | 2015-02-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800117132586 | K140949 | 000 |
08800117132517 | K140949 | 000 |
08800117132319 | K140949 | 000 |
08800117132234 | K140949 | 000 |
08800117132210 | K140949 | 000 |
08800117132135 | K140949 | 000 |