CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C— 510(k) K052798
Substantially EquivalentIsovac Products, LLC
FDA 510(k) clearance K052798 for CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C, Substantially Equivalent on 2006-06-06. Applicant: Isovac Products, LLC. Device class: 2.
Clearance details
- Applicant
- Isovac Products, LLC
- Product code
- Code LGN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5450
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellaire, TX, US
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