SOFT (HYDROPHILIC) CONTACT LENSES
FDA 510(k) clearance K982774 · decided 1998-09-02
Clearance details
- K-number
- K982774
- Device name
- SOFT (HYDROPHILIC) CONTACT LENSES
- Applicant
- Cl-Tinters
- Decision
- Substantially Equivalent
- Date received
- 1998-08-07
- Decision date
- 1998-09-02
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Helsinki, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.