The following data is part of a premarket notification filed by Pacific Dental Corp. with the FDA for Spaceline Dental Chair-unit.
Device ID | K801685 |
510k Number | K801685 |
Device Name: | SPACELINE DENTAL CHAIR-UNIT |
Classification | Unit, Operative Dental |
Applicant | PACIFIC DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-21 |
Decision Date | 1980-08-04 |