FDA · official record K053643Substantially Equivalent

STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026

Name: STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 — FDA K053643
Creator: Lifecore Biomedical, Inc.
Keywords: STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026, STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026, K053643, NHA, FDA

United StatesNHALifecore Biomedical, Inc.

Verified

Official record identity

FDA application number: K053643
Decision date: January 23, 2006
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Lifecore Biomedical, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2005-12-30
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

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.