HEINE LAMBDA 100
FDA 510(k) clearance K944156 · decided 1995-01-12
Clearance details
- K-number
- K944156
- Device name
- HEINE LAMBDA 100
- Applicant
- Heine USA , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-26
- Decision date
- 1995-01-12
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- HOX
- Device class
- 1
- Regulation number
- 886.1150
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cary, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.