ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15— 510(k) K000580

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K000580 for ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15, Substantially Equivalent on 2000-07-24. Applicant: KLS-Martin L.P..

Clearance details

Applicant
KLS-Martin L.P.
Product code
Code MQN
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
New Port Riche, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQN

product code MQN
Injury
346
Total
346

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.