The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Modu-vac Closed Suction System.
| Device ID | K944251 |
| 510k Number | K944251 |
| Device Name: | KENDALL MODU-VAC CLOSED SUCTION SYSTEM |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-31 |
| Decision Date | 1994-09-21 |