BARNES-HIND ROSE BENGAL OPHTHALMIC STR.
FDA 510(k) clearance K810285 · decided 1981-04-17
Clearance details
- K-number
- K810285
- Device name
- BARNES-HIND ROSE BENGAL OPHTHALMIC STR.
- Applicant
- Barnes-Hind, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-02-02
- Decision date
- 1981-04-17
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- KYC
- Advisory committee
- Unknown
- 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 |
|---|---|---|
| FLUORETS STERILE OPHTH. STRIPS (K831621) | Smith & Nephew, Inc. | 1983-07-18 |
| FLUORESOFT (K780125) | Holles Laboratories, Inc. | 1978-03-15 |
Recalls involving this device
No recalls on record reference this clearance.