FLUORESOFT
FDA 510(k) clearance K780125 · decided 1978-03-15
Clearance details
- K-number
- K780125
- Device name
- FLUORESOFT
- Applicant
- Holles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-24
- Decision date
- 1978-03-15
- Days to decision
- 50 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 |
| BARNES-HIND ROSE BENGAL OPHTHALMIC STR. (K810285) | Barnes-Hind, Inc. | 1981-04-17 |
Recalls involving this device
No recalls on record reference this clearance.