The following data is part of a premarket notification filed by Sds Dental, Inc. with the FDA for Delivery System(sds 1400 Xl)/delivery System Cuspidor(sds1450,sds1650 Xl).
| Device ID | K964619 |
| 510k Number | K964619 |
| Device Name: | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) |
| Classification | Unit, Operative Dental |
| Applicant | SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
| Contact | Cesar Coral |
| Correspondent | Cesar Coral SDS DENTAL, INC. 5101 N.W. 21ST AVE. N.W. SUITE 141 Fort Lauderdale, FL 33309 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-18 |
| Decision Date | 1997-01-22 |
| Summary: | summary |