Disposable Barrier Sleeves and Covers— 510(k) K160232

Substantially Equivalent

Dentsply International, Inc.

FDA 510(k) clearance K160232 for Disposable Barrier Sleeves and Covers, Substantially Equivalent on 2016-06-07. Applicant: Dentsply International, Inc..

Clearance details

Applicant: Dentsply International, Inc.
Product code: Code PEM
Advisory panel: General, Plastic Surgery
Date received: 2016-02-01
Decision date: 2016-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

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