The following data is part of a premarket notification filed by Exel Intl. with the FDA for Exel Vacuum Blood Collecting System.
| Device ID | K861152 |
| 510k Number | K861152 |
| Device Name: | EXEL VACUUM BLOOD COLLECTING SYSTEM |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-26 |
| Decision Date | 1986-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020221765363 | K861152 | 000 |
| 10020221265368 | K861152 | 000 |
| 30020221265379 | K861152 | 000 |