PRE-DENT
FDA 510(k) clearance K791200 · decided 1979-08-10
Clearance details
- K-number
- K791200
- Device name
- PRE-DENT
- Applicant
- Fichte, Graves, and Hunt
- Decision
- Substantially Equivalent
- Date received
- 1979-06-28
- Decision date
- 1979-08-10
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- GIM
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.