The following data is part of a premarket notification filed by Dentech Corp. with the FDA for Ultima 2 Dental Chair.
Device ID | K942870 |
510k Number | K942870 |
Device Name: | ULTIMA 2 DENTAL CHAIR |
Classification | Chair, Dental, With Operative Unit |
Applicant | DENTECH CORP. 529 WEST FRONT ST. Sumas, WA 98295 |
Contact | Gary Villette |
Correspondent | Gary Villette DENTECH CORP. 529 WEST FRONT ST. Sumas, WA 98295 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-17 |
Decision Date | 1995-02-27 |