EUROFLEX F-IV, ISOFLEX III
FDA 510(k) clearance K863007 · decided 1986-10-01
Clearance details
- K-number
- K863007
- Device name
- EUROFLEX F-IV, ISOFLEX III
- Applicant
- Sds Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-08
- Decision date
- 1986-10-01
- Days to decision
- 54 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.