The following data is part of a premarket notification filed by Medi-plast Intl., Inc. with the FDA for Medi-plast 2 Port Manifold (right On).
| Device ID | K954284 |
| 510k Number | K954284 |
| Device Name: | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDI-PLAST INTL., INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula MEDI-PLAST INTL., INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-30 |
| Decision Date | 1996-02-12 |