The following data is part of a premarket notification filed by Micron Corp. with the FDA for Sss, Model 1072001 (standard 4-hole Model) & 1072002 (standard 2-hole Model).
| Device ID | K032995 |
| 510k Number | K032995 |
| Device Name: | SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) |
| Classification | Scaler, Ultrasonic |
| Applicant | MICRON CORP. 1-34-14 HIGASHIYUKIGAYA Ota-ku, Tokyo, JP 145-0065 |
| Contact | Takashi Terui |
| Correspondent | Takashi Terui MICRON CORP. 1-34-14 HIGASHIYUKIGAYA Ota-ku, Tokyo, JP 145-0065 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-25 |
| Decision Date | 2003-11-20 |
| Summary: | summary |