KESTREL CONTACT LENS CASE
FDA 510(k) clearance K871714 · decided 1987-05-26
Clearance details
- K-number
- K871714
- Device name
- KESTREL CONTACT LENS CASE
- Applicant
- Applied Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-04
- Decision date
- 1987-05-26
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Columbus, IN, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S012) | Applied Laboratories, Inc. | 1994-05-19 |
| APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S010) | Applied Laboratories, Inc. | 1993-05-11 |
| APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S011) | Applied Laboratories, Inc. | 1992-09-01 |
| APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S009) | Applied Laboratories, Inc. | 1991-03-07 |
| APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S006) | Applied Laboratories, Inc. | 1990-02-16 |
| APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S005) | Applied Laboratories, Inc. | 1989-10-17 |
| APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S002) | Applied Laboratories, Inc. | 1989-04-20 |
| APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S004) | Applied Laboratories, Inc. | 1989-04-05 |