INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
FDA 510(k) clearance K935561 · decided 1994-01-26
Clearance details
- K-number
- K935561
- Device name
- INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
- Applicant
- Bausch & Lomb, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-17
- Decision date
- 1994-01-26
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JEQ
- Device class
- 1
- Regulation number
- 872.6865
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tucker, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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