The following data is part of a premarket notification filed by Medi-plast Intl., Inc. with the FDA for Medi-plast Disposable Manifold.
| Device ID | K863402 |
| 510k Number | K863402 |
| Device Name: | MEDI-PLAST DISPOSABLE MANIFOLD |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDI-PLAST INTL., INC. 8601 DUNWOODY PLACE, N.E. SUITE 330 Atlanta, GA 30338 |
| Contact | Kathleen A Lumberg |
| Correspondent | Kathleen A Lumberg MEDI-PLAST INTL., INC. 8601 DUNWOODY PLACE, N.E. SUITE 330 Atlanta, GA 30338 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-03 |
| Decision Date | 1986-10-22 |