The following data is part of a premarket notification filed by Cso with the FDA for C.s.o. Tonometer.
Device ID | K992835 |
510k Number | K992835 |
Device Name: | C.S.O. TONOMETER |
Classification | Tonometer, Manual |
Applicant | CSO 197 BELVOIR RD. Williamsville, NY 14221 |
Contact | R. Brent Miner |
Correspondent | R. Brent Miner CSO 197 BELVOIR RD. Williamsville, NY 14221 |
Product Code | HKY |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-23 |
Decision Date | 2000-06-06 |