510(k) K052798
K052798 is an FDA 510(k) premarket notification submitted by Isovac Products, LLC for the device "CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C". The FDA issued a decision of Substantially Equivalent on June 6, 2006. The device falls under product code LGN (Chamber, Patient Transport Isolation), a Class II device regulated under 21 CFR 880.5450. Isovac Products, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2006
- Date Received
- October 3, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Patient Transport Isolation
- Device Class
- Class II
- Regulation Number
- 880.5450
- Review Panel
- HO
- Submission Type