DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
FDA 510(k) clearance K911580 · decided 1991-09-24
Clearance details
- K-number
- K911580
- Device name
- DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBES
- Applicant
- Exmoor Plastics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-04-03
- Decision date
- 1991-09-24
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- ETD
- Device class
- 2
- Regulation number
- 874.3880
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Taunton, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.