FDA · official record K964342Substantially Equivalent

CYTOPLAST GBR

Name: CYTOPLAST GBR — FDA K964342
Creator: Osteogenics Co.
Keywords: CYTOPLAST GBR, CYTOPLAST GBR, K964342, LYC, FDA

United StatesLYCOsteogenics Co.

Verified

Official record identity

FDA application number: K964342
Decision date: March 11, 1997
Published decision: Substantially Equivalent

Classification

Product code: LYC

Published parties

Applicant: Osteogenics Co.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-10-31
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3930

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.