MONOJECT SCALE MAGNIFIER
FDA 510(k) clearance K781459 · decided 1978-10-24
Clearance details
- K-number
- K781459
- Device name
- MONOJECT SCALE MAGNIFIER
- Applicant
- Sherwood Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1978-08-23
- Decision date
- 1978-10-24
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- HJY
- Device class
- 1
- Regulation number
- 886.5800
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.