DENTEC 4000
FDA 510(k) clearance K894930 · decided 1990-03-27
Clearance details
- K-number
- K894930
- Device name
- DENTEC 4000
- Applicant
- Dentec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-02
- Decision date
- 1990-03-27
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Washington, D.C., DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.