The following data is part of a premarket notification filed by Southland, Ltd. with the FDA for Southland Sterile Dental System.
Device ID | K935127 |
510k Number | K935127 |
Device Name: | SOUTHLAND STERILE DENTAL SYSTEM |
Classification | Burnisher, Operative |
Applicant | SOUTHLAND, LTD. 505 COMMERCE PARK DR. SUITE H Marietta, GA 30060 |
Contact | Charles E Walker, Jr. |
Correspondent | Charles E Walker, Jr. SOUTHLAND, LTD. 505 COMMERCE PARK DR. SUITE H Marietta, GA 30060 |
Product Code | EKJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-28 |
Decision Date | 1994-07-28 |