The following data is part of a premarket notification filed by Dmc Medical Ltd. with the FDA for Cipa (adults) Cipi (infants).
| Device ID | K992932 |
| 510k Number | K992932 |
| Device Name: | CIPA (ADULTS) CIPI (INFANTS) |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DMC MEDICAL LTD. 511 CATALINA RD. Fullerton, CA 92835 |
| Contact | Charmaine Henderson |
| Correspondent | Charmaine Henderson DMC MEDICAL LTD. 511 CATALINA RD. Fullerton, CA 92835 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-31 |
| Decision Date | 2000-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530750141 | K992932 | 000 |