The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Tru-close Infection Control Evacuator.
| Device ID | K925989 |
| 510k Number | K925989 |
| Device Name: | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Paul W Evans |
| Correspondent | Paul W Evans KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-25 |
| Decision Date | 1993-02-26 |