PLASTIC OVERLAYS
FDA 510(k) clearance K911374 · decided 1991-07-26
Clearance details
- K-number
- K911374
- Device name
- PLASTIC OVERLAYS
- Applicant
- National Reading Service
- Decision
- Substantially Equivalent
- Date received
- 1991-03-28
- Decision date
- 1991-07-26
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- HKW
- Device class
- 1
- Regulation number
- 886.1650
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Peoria, 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 |
|---|---|---|
| OPTHALMIC BAR PRISM (K851555) | Roseburg SA | 1985-05-23 |
Recalls involving this device
No recalls on record reference this clearance.