The following data is part of a premarket notification filed by Cormed, Inc., Sub. C.r.bard, Inc. with the FDA for Butterfly Non-coring Needle Set.
| Device ID | K863606 |
| 510k Number | K863606 |
| Device Name: | BUTTERFLY NON-CORING NEEDLE SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
| Contact | Ankerud, Jd |
| Correspondent | Ankerud, Jd CORMED, INC., SUB. C.R.BARD, INC. 591 MAHAR ST. Medina, NY 14103 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-16 |
| Decision Date | 1986-12-18 |