SPOROX
FDA 510(k) clearance K970230 · decided 1997-10-29
Clearance details
- K-number
- K970230
- Device name
- SPOROX
- Applicant
- Reckitt Benckiser, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-21
- Decision date
- 1997-10-29
- Days to decision
- 281 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Montvale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.