IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
FDA 510(k) clearance K974837 · decided 1998-07-06
Clearance details
- K-number
- K974837
- Device name
- IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
- Applicant
- Igel Vision Care Pte , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-24
- Decision date
- 1998-07-06
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.