The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec Decade 1020 Chair.
Device ID | K913535 |
510k Number | K913535 |
Device Name: | A-DEC DECADE 1020 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 | 1991-08-09 |
Decision Date | 1991-10-09 |