DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404— 510(k) K101276

Substantially Equivalent

Chemence Medical Products, Inc.

FDA 510(k) clearance K101276 for DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404, Substantially Equivalent on 2010-07-28. Applicant: Chemence Medical Products, Inc.. Device class: 2.

Clearance details

Applicant
Chemence Medical Products, Inc.
Product code
Code MPN
Device class
Class 2
Regulation
21 CFR 878.4010
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alpharetta, GA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MPN

product code MPN
Injury
856
Other
1
Total
857

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 →

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