SEBESTYEN IRRIGATING CONTACT LENS
FDA 510(k) clearance K802927 · decided 1981-02-05
Clearance details
- K-number
- K802927
- Device name
- SEBESTYEN IRRIGATING CONTACT LENS
- Applicant
- Cooper Medical Devices Corp.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-19
- Decision date
- 1981-02-05
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- HJI
- Device class
- 1
- Regulation number
- 886.1395
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BYRNE EXPULSIVE LENS (K923670) | Ocular Instruments, Inc. | 1992-11-16 |
| 60 FUNDUS CAMERA CF-60UV (K901839) | Canon USA, Inc. | 1990-07-05 |
| STRIPE PROJECTOR (K902138) | Academic Catalyst Corp. | 1990-07-05 |
| LASER IMAGING WORK STATION (K897186) | Innovision Medical, Inc. | 1990-03-12 |
| OMS QUARTZ INFUSION CONTACT LENS (K820223) | Optical Micro Systems, Inc. | 1982-02-05 |
| LANDERS CONTACT LENS (K802971) | Cooper Medical Devices Corp. | 1981-02-05 |
| CHARLES IRRIGATING FUNDUS CONTACT LENS (K760949) | Richard'S Medical Equip., Inc. | 1976-11-11 |
Recalls involving this device
No recalls on record reference this clearance.