VISI-WIPE
FDA 510(k) clearance K884924 · decided 1989-01-31
Clearance details
- K-number
- K884924
- Device name
- VISI-WIPE
- Applicant
- Visitec Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-28
- Decision date
- 1989-01-31
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- HOF
- Device class
- 1
- Regulation number
- 886.4350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.