AGACHAMBER SPACER— 510(k) K101348

Substantially Equivalent

Aga 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
Download summary PDFView on FDA.gov ↗

Recent devices under product code NVP

view all

More clearances from Aga Plastic Ind. Com. Ltda.

view all

Adverse 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.