BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
FDA 510(k) clearance K984046 · decided 1999-01-21
Clearance details
- K-number
- K984046
- Device name
- BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS
- Applicant
- Ocular Sciences Puerto Rico, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-12
- Decision date
- 1999-01-21
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rockville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.