The following data is part of a premarket notification filed by Whaledent Intl. Div. Ipco with the FDA for Biosonic Ultrasonic Cleaning System.
| Device ID | K884660 |
| 510k Number | K884660 |
| Device Name: | BIOSONIC ULTRASONIC CLEANING SYSTEM |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | WHALEDENT INTL. DIV. IPCO CONSULTANT 36 MAPLEWOOD ROAD Hartsdale, NY 10530 |
| Contact | L Wolfson |
| Correspondent | L Wolfson WHALEDENT INTL. DIV. IPCO CONSULTANT 36 MAPLEWOOD ROAD Hartsdale, NY 10530 |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-03-16 |