The following data is part of a premarket notification filed by Kowa Optimed, Inc. with the FDA for Kowa Hand-held Applanation Tonometer Ha-1.
| Device ID | K960924 |
| 510k Number | K960924 |
| Device Name: | KOWA HAND-HELD APPLANATION TONOMETER HA-1 |
| Classification | Tonometer, Manual |
| Applicant | KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Contact | Samia N Rodriquez, Esq. |
| Correspondent | Samia N Rodriquez, Esq. KOWA OPTIMED, INC. 700 THIRTEENTH STREET, N.W. SUITE 1200 Washington, DC 20005 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-06 |
| Decision Date | 1996-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987646803799 | K960924 | 000 |