The following data is part of a premarket notification filed by Ihara Medics U.s., Inc. with the FDA for Ketorex C Sanwa.
| Device ID | K953452 |
| 510k Number | K953452 |
| Device Name: | KETOREX C SANWA |
| Classification | Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase |
| Applicant | IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K Valencia, CA 91355 |
| Contact | Leonard Spolter |
| Correspondent | Leonard Spolter IHARA MEDICS U.S., INC. 25030 AVENUE TIBBITS, UNIT K Valencia, CA 91355 |
| Product Code | JMK |
| CFR Regulation Number | 862.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-18 |
| Decision Date | 1996-05-02 |