The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Tbi Needle.
| Device ID | K860582 |
| 510k Number | K860582 |
| Device Name: | TBI NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Contact | Steven G Richter |
| Correspondent | Steven G Richter HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-18 |
| Decision Date | 1986-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M84946210 | K860582 | 000 |