The following data is part of a premarket notification filed by C.s.o. S.r.l. with the FDA for F 900.
| Device ID | K022054 |
| 510k Number | K022054 |
| Device Name: | F 900 |
| Classification | Tonometer, Manual |
| Applicant | C.S.O. S.R.L. 197 BELVOIR RD. Williamsville, NY 14221 |
| Contact | R. Brent Miner |
| Correspondent | R. Brent Miner C.S.O. S.R.L. 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 | 2002-06-24 |
| Decision Date | 2002-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08056098470517 | K022054 | 000 |
| 08056098470425 | K022054 | 000 |