AIRCRAFT TRANSIT ISOLATOR MODEL 121
FDA 510(k) clearance K790658 · decided 1979-07-03
Clearance details
- K-number
- K790658
- Device name
- AIRCRAFT TRANSIT ISOLATOR MODEL 121
- Applicant
- Vickers America Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-04-05
- Decision date
- 1979-07-03
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- LGN
- Device class
- 2
- Regulation number
- 880.5450
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C (K052798) | Isovac Products, LLC | 2006-06-06 |
Recalls involving this device
No recalls on record reference this clearance.