The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Siemens Sirona(r) Dental Chair.
Device ID | K863484 |
510k Number | K863484 |
Device Name: | SIEMENS SIRONA(R) DENTAL CHAIR |
Classification | Chair, Dental, With Operative Unit |
Applicant | PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
Contact | Philip L Whitson |
Correspondent | Philip L Whitson PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
Product Code | KLC |
CFR Regulation Number | 872.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-09 |
Decision Date | 1986-09-19 |