The following data is part of a premarket notification filed by Exelint International Co. with the FDA for Exel Butterfly Scalp Vein Set.
| Device ID | K020189 |
| 510k Number | K020189 |
| Device Name: | EXEL BUTTERFLY SCALP VEIN SET |
| Classification | Set, Administration, Intravascular |
| Applicant | EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. Los Angeles, CA 90231 -3194 |
| Contact | Tammie Ewing |
| Correspondent | Tammie Ewing EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. Los Angeles, 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 | 2002-01-18 |
| Decision Date | 2003-03-27 |