Aegis Transit System
FDA 510(k) clearance K170757 · decided 2017-07-14
Clearance details
- K-number
- K170757
- Device name
- Aegis Transit System
- Applicant
- Boston-Biomedical Associates
- Decision
- Substantially Equivalent
- Date received
- 2017-03-13
- Decision date
- 2017-07-14
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- EWY
- Device class
- 2
- Regulation number
- 874.4720
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
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| FLEXIBLE TROCAR TUBES (K930215) | Olympus Corp. | 1993-03-16 |
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Recalls involving this device
No recalls on record reference this clearance.