FDA · official record K040671Substantially Equivalent

EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

Name: EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES — FDA K040671
Creator: Anthogyr
Keywords: EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES, EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES, K040671, EJI, FDA

United StatesEJIAnthogyr

Verified

Official record identity

FDA application number: K040671
Decision date: December 14, 2004
Published decision: Substantially Equivalent

Classification

Product code: EJI

Published parties

Applicant: Anthogyr

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2004-03-15
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6770

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.