The following data is part of a premarket notification filed by Chattanooga Group, Inc. with the FDA for Hand Held Goniometer.
Device ID | K850082 |
510k Number | K850082 |
Device Name: | HAND HELD GONIOMETER |
Classification | Goniometer, Nonpowered |
Applicant | CHATTANOOGA GROUP, INC. 101 MEMORIAL DR. Red Bank, TN 37405 |
Contact | Maley |
Correspondent | Maley CHATTANOOGA GROUP, INC. 101 MEMORIAL DR. Red Bank, TN 37405 |
Product Code | KQW |
CFR Regulation Number | 888.1520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-10 |
Decision Date | 1985-04-04 |