The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Filter, I.v., With Flash Bulb (#4701).
| Device ID | K760111 |
| 510k Number | K760111 |
| Device Name: | FILTER, I.V., WITH FLASH BULB (#4701) |
| Classification | Set, Administration, Intravascular |
| Applicant | JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-24 |
| Decision Date | 1976-07-16 |