The following data is part of a premarket notification filed by Advocacy International, Ltd. with the FDA for Lipase Uv [toyo].
| Device ID | K874027 |
| 510k Number | K874027 |
| Device Name: | LIPASE UV [TOYO] |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | ADVOCACY INTERNATIONAL, LTD. INTERNATIONA SQUARE 1825 EYE STREET N.W. SUITE 400 Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney ADVOCACY INTERNATIONAL, LTD. INTERNATIONA SQUARE 1825 EYE STREET N.W. SUITE 400 Washington, DC 20006 |
| Product Code | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-02 |
| Decision Date | 1988-05-27 |