AGACHAMBER SPACER— 510(k) K101348
Substantially EquivalentAga Plastic Ind. Com. Ltda.
FDA 510(k) clearance K101348 for AGACHAMBER SPACER, Substantially Equivalent on 2011-04-29. Applicant: Aga Plastic Ind. Com. Ltda.. Device class: 2.
Clearance details
- Applicant
- Aga Plastic Ind. Com. Ltda.
- Product code
- Code NVP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
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More clearances from Aga Plastic Ind. Com. Ltda.
view allAdverse events under product code NVP
product code NVP- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.