S.T.P.B SOFT TISSUES PROTECTIVES BLADES
FDA 510(k) clearance K854467 · decided 1986-03-12
Clearance details
- K-number
- K854467
- Device name
- S.T.P.B SOFT TISSUES PROTECTIVES BLADES
- Applicant
- Nortex USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-06
- Decision date
- 1986-03-12
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- EEJ
- Device class
- 1
- Regulation number
- 872.6010
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.