B.U.S. ENDOTRON
FDA 510(k) clearance K972148 · decided 1997-12-10
Clearance details
- K-number
- K972148
- Device name
- B.U.S. ENDOTRON
- Applicant
- Medicamat S.A.
- Decision
- Substantially Equivalent
- Date received
- 1997-06-09
- Decision date
- 1997-12-10
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- 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.