The following data is part of a premarket notification filed by Physical Diagnostics, Inc. with the FDA for Tpg 1000.
Device ID | K831002 |
510k Number | K831002 |
Device Name: | TPG 1000 |
Classification | Component, Traction, Non-invasive |
Applicant | PHYSICAL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQZ |
CFR Regulation Number | 888.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-29 |
Decision Date | 1983-06-24 |