W&H MICRO MOTOR E25 (WITHOUT LIGHT)
FDA 510(k) clearance K944712 · decided 1995-08-25
Clearance details
- K-number
- K944712
- Device name
- W&H MICRO MOTOR E25 (WITHOUT LIGHT)
- Applicant
- A-Dec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-23
- Decision date
- 1995-08-25
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Newberg, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.