APPOSE ULE STERILE DISPOS. SKIN STAP— 510(k) K840177

Substantially Equivalent

Davis & Geck, Inc.

FDA 510(k) clearance K840177 for APPOSE ULE STERILE DISPOS. SKIN STAP, Substantially Equivalent on 1984-03-05. Applicant: Davis & Geck, Inc.. Device class: 2.

Clearance details

Applicant
Davis & Geck, Inc.
Product code
Code GAG
Device class
Class 2
Regulation
21 CFR 878.4740
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GAG

product code GAG
Death
23
Injury
394
Malfunction
2,304
Other
6
Total
2,727

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.