The following data is part of a premarket notification filed by Barnstead/thermolyne Corp. with the FDA for Sterilemax.
Device ID | K953938 |
510k Number | K953938 |
Device Name: | STERILEMAX |
Classification | Sterilizer, Steam |
Applicant | BARNSTEAD/THERMOLYNE CORP. 2555 KERPER BLVD. Dubuque, IA 52001 |
Contact | Craig T Case |
Correspondent | Craig T Case BARNSTEAD/THERMOLYNE CORP. 2555 KERPER BLVD. Dubuque, IA 52001 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-21 |
Decision Date | 1997-01-30 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STERILEMAX 75129834 2229329 Live/Registered |
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC 1996-07-03 |