The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Butterfly Scalp Vein Set.
| Device ID | K862491 |
| 510k Number | K862491 |
| Device Name: | EXEL BUTTERFLY SCALP VEIN SET |
| Classification | Set, Administration, Intravascular |
| Applicant | EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Contact | Eshagh Hamid |
| Correspondent | Eshagh Hamid EXEL INTL. P.O. BOX 3194 Culver City, CA 90231 -3194 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1986-08-27 |