BENTLEY-TRANTEC DISPOS. DOMES D-260-
FDA 510(k) clearance K841811 · decided 1985-09-09
Clearance details
- K-number
- K841811
- Device name
- BENTLEY-TRANTEC DISPOS. DOMES D-260-
- Applicant
- American Bentley
- Decision
- Substantially Equivalent
- Date received
- 1984-05-01
- Decision date
- 1985-09-09
- Days to decision
- 496 days
- Clearance type
- Traditional
- Product code
- DRS
- Device class
- 2
- Regulation number
- 870.2850
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.