REUTER BOBBIN VENTILA. TUBE-TITANIUM
FDA 510(k) clearance K820362 · decided 1982-03-02
Clearance details
- K-number
- K820362
- Device name
- REUTER BOBBIN VENTILA. TUBE-TITANIUM
- Applicant
- Richard'S Medical Equip., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-09
- Decision date
- 1982-03-02
- Days to decision
- 21 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS recall (Z-0797-2010) | Gyrus ACMI Corporation | 2010-03-04 |