The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall T.e.d./scd Sequential Compression Device.
| Device ID | K932835 |
| 510k Number | K932835 |
| Device Name: | KENDALL T.E.D./SCD SEQUENTIAL COMPRESSION DEVICE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | John Vozella |
| Correspondent | John Vozella KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-10 |
| Decision Date | 1993-08-06 |