The following data is part of a premarket notification filed by Cormed, Inc., Sub. C.r.bard, Inc. with the FDA for Cormed Huber Point Needle.
| Device ID | K843083 |
| 510k Number | K843083 |
| Device Name: | CORMED HUBER POINT NEEDLE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | CORMED, INC., SUB. C.R.BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-06 |
| Decision Date | 1984-09-05 |