VALTRAC PURSESTING DEVICE— 510(k) K851452

Substantially Equivalent

Davis & Geck, Inc.

FDA 510(k) clearance K851452 for VALTRAC PURSESTING DEVICE, Substantially Equivalent on 1985-06-12. Applicant: Davis & Geck, Inc.. Device class: 1.

Clearance details

Applicant
Davis & Geck, Inc.
Product code
Code HCF
Device class
Class 1
Regulation
21 CFR 878.4800
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Danbury, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HCF

product code HCF
Death
6
Other
1
Total
7

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.