OPHTHALMIC FLUID DISTRIBUTION SETS
FDA 510(k) clearance K923972 · decided 1992-11-04
Clearance details
- K-number
- K923972
- Device name
- OPHTHALMIC FLUID DISTRIBUTION SETS
- Applicant
- Visitec Co.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-07
- Decision date
- 1992-11-04
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- FPK
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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.