The following data is part of a premarket notification filed by Hpd Medical, Inc. with the FDA for Hpd Tubing Connectors.
| Device ID | K895795 |
| 510k Number | K895795 |
| Device Name: | HPD TUBING CONNECTORS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | HPD MEDICAL, INC. 1000 CALLE NEGOCIO San Clemente, CA 92672 -6205 |
| Contact | Howard V Rowe |
| Correspondent | Howard V Rowe HPD MEDICAL, INC. 1000 CALLE NEGOCIO San Clemente, CA 92672 -6205 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-27 |
| Decision Date | 1990-01-26 |