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 |