BONASSE CONTACT LENS CASE
FDA 510(k) clearance K991206 · decided 2000-06-06
Clearance details
- K-number
- K991206
- Device name
- BONASSE CONTACT LENS CASE
- Applicant
- Bonasse Ent. Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-09
- Decision date
- 2000-06-06
- Days to decision
- 424 days
- Clearance type
- Traditional
- Product code
- LRX
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.