The following data is part of a premarket notification filed by Keeler Ltd. with the FDA for Keeler Applanation Tonometer; T-type Kat, K-type Kat, (kat).
| Device ID | K093445 |
| 510k Number | K093445 |
| Device Name: | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) |
| Classification | Tonometer, Manual |
| Applicant | KEELER LTD. 456 PARKWAY Broomall, PA 19008 |
| Contact | Eugene R Vanarsdale |
| Correspondent | Eugene R Vanarsdale KEELER LTD. 456 PARKWAY Broomall, PA 19008 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-21 |
| Decision Date | 2010-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272716529 | K093445 | 000 |
| 05055272712194 | K093445 | 000 |
| 05055272711722 | K093445 | 000 |