The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ulticare Disposable Syringes And Needles.
| Device ID | K062702 |
| 510k Number | K062702 |
| Device Name: | ULTICARE DISPOSABLE SYRINGES AND NEEDLES |
| Classification | Syringe, Piston |
| Applicant | ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 -1334 |
| Contact | Carole Stamp |
| Correspondent | Carole Stamp ULTIMED, INC. 5353 WAYZATA BLVD. SUITE 505 Minneapolis, MN 55416 -1334 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2006-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10370030128768 | K062702 | 000 |
| 00070030510732 | K062702 | 000 |
| 00070030510725 | K062702 | 000 |
| 00070030510718 | K062702 | 000 |
| 00070030510701 | K062702 | 000 |
| 00070030510695 | K062702 | 000 |
| 10883967398185 | K062702 | 000 |
| 10883967398178 | K062702 | 000 |
| 10883967398161 | K062702 | 000 |
| 10883967398154 | K062702 | 000 |
| 00070030510749 | K062702 | 000 |
| 00070030510756 | K062702 | 000 |
| 10370030128751 | K062702 | 000 |
| 10370030128744 | K062702 | 000 |
| 10370030128737 | K062702 | 000 |
| 10370030128720 | K062702 | 000 |
| 10370030128713 | K062702 | 000 |
| 10370030128706 | K062702 | 000 |
| 10370030128690 | K062702 | 000 |
| 00070030510770 | K062702 | 000 |
| 00070030510763 | K062702 | 000 |
| 10883967398147 | K062702 | 000 |