GENT-L-KARE LACERATION TRAYS— 510(k) K950850

Clearance details

Applicant

Premium Plastics, Inc.

Product code

Code FRG

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

1995-02-24

Decision date

1995-03-14

Decision

Substantially Equivalent for Some Indications

Clearance type

Traditional

Location

Chicago, IL, 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 →