The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Pressure Sensing Syringe 65000.
| Device ID | K853586 |
| 510k Number | K853586 |
| Device Name: | PRESSURE SENSING SYRINGE 65000 |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Ronald A Williams |
| Correspondent | Ronald A Williams DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1985-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994918530 | K853586 | 000 |
| 20613994918493 | K853586 | 000 |