FDA · official record K800138Substantially Equivalent

TS-301 THREE-WAY PULP TESTER

Name: TS-301 THREE-WAY PULP TESTER — FDA K800138
Creator: Tamler-Stoneham Instruments
Keywords: TS-301 THREE-WAY PULP TESTER, TS-301 THREE-WAY PULP TESTER, K800138, EAT, FDA

United StatesEATTamler-Stoneham Instruments

Verified

Official record identity

FDA application number: K800138
Decision date: February 13, 1980
Published decision: Substantially Equivalent

Classification

Product code: EAT

Published parties

Applicant: Tamler-Stoneham Instruments

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1980-01-21
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1720

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.