The following data is part of a premarket notification filed by San Diego Swiss Machining, Inc. with the FDA for Sapphire Plus Scaler Mod. 300114/plugger Mod. 300115/cutting Mod. 300116/spreader Mod. 300117 Tips.
| Device ID | K960889 |
| 510k Number | K960889 |
| Device Name: | SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS |
| Classification | Scaler, Ultrasonic |
| Applicant | SAN DIEGO SWISS MACHINING, INC. 8910 UNIVERSITY CENTER LN. SUITE 265 San Diego, CA 92122 -1085 |
| Contact | Alan Donald |
| Correspondent | Alan Donald SAN DIEGO SWISS MACHINING, INC. 8910 UNIVERSITY CENTER LN. SUITE 265 San Diego, CA 92122 -1085 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-04 |
| Decision Date | 1996-05-10 |
| Summary: | summary |