The following data is part of a premarket notification filed by Progressive Medical Technology, Inc. with the FDA for Talley Tm300 Sequential Multicom Compression Syst.
Device ID | K915092 |
510k Number | K915092 |
Device Name: | TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST |
Classification | Massager, Powered Inflatable Tube |
Applicant | PROGRESSIVE MEDICAL TECHNOLOGY, INC. 815 TERMINAL RD. Lansing, MI 48906 |
Contact | Van Dyke |
Correspondent | Van Dyke PROGRESSIVE MEDICAL TECHNOLOGY, INC. 815 TERMINAL RD. Lansing, MI 48906 |
Product Code | IRP |
CFR Regulation Number | 890.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-11-21 |
Decision Date | 1992-02-11 |