FDA · official record K161106Substantially Equivalent

PANPAC DISPOSABLE VACUUM CURETTES

Name: PANPAC DISPOSABLE VACUUM CURETTES — FDA K161106
Creator: Panpac Medical Corporation
Keywords: PANPAC DISPOSABLE VACUUM CURETTES, PANPAC DISPOSABLE VACUUM CURETTES, K161106, HGH, FDA

United StatesHGHPanpac Medical Corporation

Verified

Official record identity

FDA application number: K161106
Decision date: January 13, 2017
Published decision: Substantially Equivalent

Classification

Product code: HGH

Published parties

Applicant: Panpac Medical Corporation

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2016-04-19
Review panel: Obstetrics/Gynecology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 884.5070

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.