The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for O'brien Goniometer.
Device ID | K926237 |
510k Number | K926237 |
Device Name: | O'BRIEN GONIOMETER |
Classification | Goniometer, Nonpowered |
Applicant | SGARLATO LABORATORIES, INC. 100 O'CONNOR DR, SUITE 18 San Jose, CA 95128 |
Contact | Thomas E Sgarlato |
Correspondent | Thomas E Sgarlato SGARLATO LABORATORIES, INC. 100 O'CONNOR DR, SUITE 18 San Jose, CA 95128 |
Product Code | KQW |
CFR Regulation Number | 888.1520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-11 |
Decision Date | 1993-08-02 |