Surgical Angle Handpiece, Surgical Straight Handpiece
FDA 510(k) clearance K171155 · decided 2017-11-21
Clearance details
- K-number
- K171155
- Device name
- Surgical Angle Handpiece, Surgical Straight Handpiece
- Applicant
- Nakanishi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-04-20
- Decision date
- 2017-11-21
- Days to decision
- 215 days
- Clearance type
- Traditional
- Product code
- KMW
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Kanuma-Shi, JP
- Third-party review
- No
- Expedited review
- No
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