The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for Cabinet Ii Auxiliary Unit.
Device ID | K863023 |
510k Number | K863023 |
Device Name: | CABINET II AUXILIARY UNIT |
Classification | Unit, Operative Dental |
Applicant | SDS DENTAL, INC. 4321 WISCONSIN AVE N.W SUITE 200 Washington, DC 20016 |
Contact | Cesar Coral |
Correspondent | Cesar Coral SDS DENTAL, INC. 4321 WISCONSIN AVE N.W SUITE 200 Washington, DC 20016 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-08 |
Decision Date | 1986-09-25 |