The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Aspirating Needle, Catalog Code #12006.
| Device ID | K865079 |
| 510k Number | K865079 |
| Device Name: | ASPIRATING NEEDLE, CATALOG CODE #12006 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Contact | Williams, Phd |
| Correspondent | Williams, Phd DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-29 |
| Decision Date | 1987-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994794578 | K865079 | 000 |