The following data is part of a premarket notification filed by Keeler Limited with the FDA for Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box Of 100.
| Device ID | K152644 |
| 510k Number | K152644 |
| Device Name: | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 |
| Classification | Tonometer, Manual |
| Applicant | KEELER LIMITED CLEWER HILL ROAD Windsor, GB Sl4 4aa |
| Contact | Irina Proutski |
| Correspondent | Eugene R. Van Arsdale KEELER INSTRUMENTS, INC. 456 PARKWAY Broomall, PA 19008 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-16 |
| Decision Date | 2015-12-31 |