The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Tomey Proton Tonometer.
Device ID | K924760 |
510k Number | K924760 |
Device Name: | TOMEY PROTON TONOMETER |
Classification | Tonometer, Manual |
Applicant | TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
Contact | Lori A Truitt |
Correspondent | Lori A Truitt TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
Product Code | HKY |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-23 |
Decision Date | 1993-04-05 |