HOLD-IT FRAMED ADHESIVE FILM— 510(k) K860071

Substantially Equivalent

Vlv Associates, Inc.

FDA 510(k) clearance K860071 for HOLD-IT FRAMED ADHESIVE FILM, Substantially Equivalent on 1986-01-27. Applicant: Vlv Associates, Inc.. Device class: 1.

Clearance details

Applicant
Vlv Associates, Inc.
Product code
Code KMK
Device class
Class 1
Regulation
21 CFR 880.5210
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
East Hanover, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KMK

product code KMK
Malfunction
461
Other
1
Total
462

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.