The following data is part of a premarket notification filed by Tamler-stoneham Instruments with the FDA for Ts-301 Three-way Pulp Tester.
Device ID | K800138 |
510k Number | K800138 |
Device Name: | TS-301 THREE-WAY PULP TESTER |
Classification | Tester, Pulp |
Applicant | TAMLER-STONEHAM INSTRUMENTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EAT |
CFR Regulation Number | 872.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-21 |
Decision Date | 1980-02-13 |