The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for Baumer Surgical Table.
Device ID | K902865 |
510k Number | K902865 |
Device Name: | BAUMER SURGICAL TABLE |
Classification | Table And Attachments, Operating-room |
Applicant | SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
Contact | Cesar R Coral |
Correspondent | Cesar R Coral SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
Product Code | BWN |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-29 |
Decision Date | 1990-09-10 |