The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Scd Therapeutic Stocking System.
Device ID | K902497 |
510k Number | K902497 |
Device Name: | SCD THERAPEUTIC STOCKING SYSTEM |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Contact | John J Vozella |
Correspondent | John J Vozella KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-05 |
Decision Date | 1990-08-15 |