STABILTUBE
FDA 510(k) clearance K934117 · decided 1993-10-25
Clearance details
- K-number
- K934117
- Device name
- STABILTUBE
- Applicant
- Garrett Medical Products
- Decision
- Substantially Equivalent
- Date received
- 1993-08-24
- Decision date
- 1993-10-25
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Rancho Santa Margarita, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.