FDA · official record K964619Substantially Equivalent

DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)

Name: DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) — FDA K964619
Creator: Sds Dental, Inc.
Keywords: DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL), DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL), K964619, EIA, FDA

United StatesEIASds Dental, Inc.

Verified

Official record identity

FDA application number: K964619
Decision date: January 22, 1997
Published decision: Substantially Equivalent

Classification

Product code: EIA

Published parties

Applicant: Sds Dental, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-11-18
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

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.