The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for W & H Lisa Steam Sterilizer.
Device ID | K022816 |
510k Number | K022816 |
Device Name: | W & H LISA STEAM STERILIZER |
Classification | Sterilizer, Steam |
Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Contact | Tom Louisell |
Correspondent | Tom Louisell A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Product Code | FLE |
CFR Regulation Number | 880.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-26 |
Decision Date | 2003-02-07 |