The following data is part of a premarket notification filed by Tuttnauer Usa Co. Ltd. with the FDA for Tuttnauer Ehs Series Table-top Autoclave, Model 2540.
Device ID | K021504 |
510k Number | K021504 |
Device Name: | TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 |
Classification | Sterilizer, Steam |
Applicant | TUTTNAUER USA CO. LTD. 1776 K STREET, N.W. SUITE 800 Washington, DC 20006 -7910 |
Contact | Todd H Halpern |
Correspondent | Todd H Halpern TUTTNAUER USA CO. LTD. 1776 K STREET, N.W. SUITE 800 Washington, DC 20006 -7910 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-09 |
Decision Date | 2002-07-25 |
Summary: | summary |