The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec Kneebreak 1030 Chair.
Device ID | K913059 |
510k Number | K913059 |
Device Name: | A-DEC KNEEBREAK 1030 CHAIR |
Classification | Chair, Dental, With Operative Unit |
Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Contact | Kurt Nichols |
Correspondent | Kurt Nichols A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-10 |
Decision Date | 1991-10-08 |