510(k) K052798
- Device
- CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
- Applicant
- ISOVAC PRODUCTS LLC
- 510(k) number
- K052798
- Product code
- LGN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-06
- Date received
- 2005-10-03
- Regulation
- 880.5450
- Classification name
- Chamber, Patient Transport Isolation
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LISA S JONES
- Address
- 540 College St. Bellaire TX US 77401 77401
FDA Registration Numbers#
- 3006076009
Source Documents#
Other 510(k) Records For Product Code LGN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K790658 | AIRCRAFT TRANSIT ISOLATOR MODEL 121 | Vickers America Medical Corp. | 1979-07-03 |
Legacy Summary#
summary
FDA Review#
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