The following data is part of a premarket notification filed by Mbo Laboratories, Inc. with the FDA for Angel Wing Safety Blood Collection With Tube Hold..
| Device ID | K920184 |
| 510k Number | K920184 |
| Device Name: | ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | MBO LABORATORIES, INC. P.O. BOX 948 110 MIDDLESEX STREET North Chelmsford, MA 01863 |
| Contact | Jacob B Blecher |
| Correspondent | Jacob B Blecher MBO LABORATORIES, INC. P.O. BOX 948 110 MIDDLESEX STREET North Chelmsford, MA 01863 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-15 |
| Decision Date | 1992-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521013237 | K920184 | 000 |
| 20884521013305 | K920184 | 000 |
| 20884521013282 | K920184 | 000 |
| 20884521013251 | K920184 | 000 |
| 20884521013152 | K920184 | 000 |
| 20884521013084 | K920184 | 000 |