FDA · official record K011748Substantially Equivalent

FIRST FILL R.C.S.

Name: FIRST FILL R.C.S. — FDA K011748
Creator: Jeneric/Pentron, Inc.
Keywords: FIRST FILL R.C.S., FIRST FILL R.C.S., K011748, KIF, FDA

United StatesKIFJeneric/Pentron, Inc.

Verified

Official record identity

FDA application number: K011748
Decision date: August 03, 2001
Published decision: Substantially Equivalent

Classification

Product code: KIF

Published parties

Applicant: Jeneric/Pentron, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2001-06-06
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3820

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.