The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec/w&h Electric Motor, Model Ea-50lt.
Device ID | K032572 |
510k Number | K032572 |
Device Name: | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT |
Classification | Controller, Foot, Handpiece And Cord |
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 | EBW |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-20 |
Decision Date | 2003-12-03 |