The following data is part of a premarket notification filed by Micron Corp. with the FDA for Vip 60 (2h), Model 115-000-1, Vip 60 (4h), Model 115-000-2.
| Device ID | K991239 |
| 510k Number | K991239 |
| Device Name: | VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 |
| Classification | Scaler, Ultrasonic |
| Applicant | MICRON CORP. 1-34-14 HIGASHIYUKIGAYA Ohta-ku, Tokyo, JP 145-0065 |
| Contact | Eiji Suzuki |
| Correspondent | Eiji Suzuki MICRON CORP. 1-34-14 HIGASHIYUKIGAYA Ohta-ku, Tokyo, JP 145-0065 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-10-18 |