510(k) K802971
- Device
- LANDERS CONTACT LENS
- Applicant
- COOPER MEDICAL DEVICES CORP.
- 510(k) number
- K802971
- Product code
- HJI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-02-05
- Date received
- 1980-11-21
- Regulation
- 886.1395
- Classification name
- Lens, Fundus, Hruby, Diagnostic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3033485955
- 1928237
- 3015456951
- 3011898560
- 3012185136
- 3003951061
- 3003398873
- 3005941719
- 3031231776
- 1058726
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HJI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923670 | BYRNE EXPULSIVE LENS | Ocular Instruments, Inc. | 1992-11-16 |
| K901839 | 60 FUNDUS CAMERA CF-60UV | Canon USA, Inc. | 1990-07-05 |
| K902138 | STRIPE PROJECTOR | Academic Catalyst Corp. | 1990-07-05 |
| K897186 | LASER IMAGING WORK STATION | Innovision Medical, Inc. | 1990-03-12 |
| K820223 | OMS QUARTZ INFUSION CONTACT LENS | Optical Micro Systems, Inc. | 1982-02-05 |
| K802927 | SEBESTYEN IRRIGATING CONTACT LENS | Cooper Medical Devices Corp. | 1981-02-05 |
| K760949 | CHARLES IRRIGATING FUNDUS CONTACT LENS | Richard'S Medical Equip., Inc. | 1976-11-11 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases