GO-CLEAN
FDA 510(k) clearance K922110 · decided 1994-03-09
Clearance details
- K-number
- K922110
- Device name
- GO-CLEAN
- Applicant
- Viva-Tek Assoc., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-05
- Decision date
- 1994-03-09
- Days to decision
- 673 days
- Clearance type
- Traditional
- Product code
- FRR
- Device class
- 2
- Regulation number
- 880.5450
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Medford, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.