The following data is part of a premarket notification filed by Mbo Laboratories, Inc. with the FDA for Angel Wing Sets -- Modified.
| Device ID | K922468 |
| 510k Number | K922468 |
| Device Name: | ANGEL WING SETS -- MODIFIED |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | MBO LABORATORIES, INC. P.O. BOX 948 110 MIDDLESEX STREET North Chelmsford, MA 01863 |
| Contact | J. B Blecher |
| Correspondent | J. 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 | 1992-05-13 |
| Decision Date | 1992-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521013206 | K922468 | 000 |
| 20884521013183 | K922468 | 000 |