The following data is part of a premarket notification filed by Gisco Intl. with the FDA for Hemo-nate Syringe Blood Filter.
| Device ID | K781815 |
| 510k Number | K781815 |
| Device Name: | HEMO-NATE SYRINGE BLOOD FILTER |
| Classification | Filter, Infusion Line |
| Applicant | GISCO INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-24 |
| Decision Date | 1979-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67140206091 | K781815 | 000 |
| H67140205091 | K781815 | 000 |
| H67140200091 | K781815 | 000 |
| H67140200071 | K781815 | 000 |
| H67140200051 | K781815 | 000 |