SANI-SHIELD
FDA 510(k) clearance K970104 · decided 1997-05-06
Clearance details
- K-number
- K970104
- Device name
- SANI-SHIELD
- Applicant
- Dw Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-13
- Decision date
- 1997-05-06
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.