STERI-LOK DUAL PURPOSE PACKAGING/8400— 510(k) K811670

Clearance details

Applicant

3M Company

Product code

Code FRG

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

1981-06-15

Decision date

1981-07-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

White City, OR, US

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Other

3

Total

3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →