HYLASHIELD CL
FDA 510(k) clearance K994170 · decided 2000-03-02
Clearance details
- K-number
- K994170
- Device name
- HYLASHIELD CL
- Applicant
- Biomatrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-10
- Decision date
- 2000-03-02
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- MRC
- Device class
- 2
- Regulation number
- 886.5918
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Ridgefield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.