The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec/w&h Electric Handpiece Motor.
Device ID | K133776 |
510k Number | K133776 |
Device Name: | A-DEC/W&H ELECTRIC HANDPIECE MOTOR |
Classification | Controller, Foot, Handpiece And Cord |
Applicant | A-DEC, INC. 2601 CRESTVIEW AVE. Newberg, OR 97132 |
Contact | Bonnie Dundas |
Correspondent | Bonnie Dundas A-DEC, INC. 2601 CRESTVIEW AVE. Newberg, OR 97132 |
Product Code | EBW |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-12 |
Decision Date | 2014-05-28 |
Summary: | summary |