The following data is part of a premarket notification filed by Mbo Laboratories, Inc. with the FDA for Angel Wing Safety Blood Collection And Infusion Se.
| Device ID | K912563 |
| 510k Number | K912563 |
| Device Name: | ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MBO LABORATORIES, INC. 225 STEDMAN STREET, STE.30 Lowell, MA 01850 |
| Contact | Jacob B Blecher |
| Correspondent | Jacob B Blecher MBO LABORATORIES, INC. 225 STEDMAN STREET, STE.30 Lowell, MA 01850 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-11 |
| Decision Date | 1991-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521013077 | K912563 | 000 |
| 20884521013121 | K912563 | 000 |
| 20884521013329 | K912563 | 000 |
| 20884521013350 | K912563 | 000 |
| 20884521013398 | K912563 | 000 |
| 20884521013435 | K912563 | 000 |
| 20884521013916 | K912563 | 000 |
| 20884521013930 | K912563 | 000 |
| 20884521013961 | K912563 | 000 |
| 20884521013985 | K912563 | 000 |
| 20884521012971 | K912563 | 000 |
| 20884521012995 | K912563 | 000 |
| 20884521013015 | K912563 | 000 |