510(k) K911734
- Device
- TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM
- Applicant
- Northland Cataract & Eye Care Clinic
- 510(k) number
- K911734
- Product code
- KYD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-11-07
- Date received
- 1991-04-17
- Regulation
- 886.1800
- Classification name
- Strip, Schirmer
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JERRY W COOK
- Address
- 5500 N. Oak, Suite 202 Kansas City MO US 64118 64118
FDA Registration Numbers#
- 1610287
- 1649518
- 3008449456
- 3004475955
- 8044131
- 3017609685
- 3012185136
- 3003951061
- 2085143
- 1937310
- 3031231776
- 3042228518
- 2029275
- 2242450
- 3004950803
- 3006550126
- 3008812251
- 3007317099
- 3038187458
- 3004765453
- 3008559295
- 3003860739
- 3003860763
- 2953359
- 1058726
Source Documents#
510(k) summary PDF not indicated by FDA