The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Pharmaseal Thoracentesis Tray W/univ Drainage Set.
| Device ID | K910693 |
| 510k Number | K910693 |
| Device Name: | PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET |
| Classification | Catheter And Tip, Suction |
| Applicant | BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
| Contact | David A Harreld |
| Correspondent | David A Harreld BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia, CA 91355 -8900 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-19 |
| Decision Date | 1991-10-17 |