3M WOUND CONTACT MATERIAL, PRODUCT #563X— 510(k) K881988

Substantially Equivalent

3M Company

FDA 510(k) clearance K881988 for 3M WOUND CONTACT MATERIAL, PRODUCT #563X, Substantially Equivalent on 1988-06-27. Applicant: 3M Company. Device class: 1.

Clearance details

Applicant
3M Company
Product code
Code NAD
Device class
Class 1
Regulation
21 CFR 878.4020
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cottae Grove, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NAD

product code NAD
Injury
431
Malfunction
11,935
Other
1
Total
12,367

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.