The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Ucs-2, Ultrasonic Cleaning Solution.
| Device ID | K861147 |
| 510k Number | K861147 |
| Device Name: | UCS-2, ULTRASONIC CLEANING SOLUTION |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England, GB |
| Contact | R. L Gray |
| Correspondent | R. L Gray KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England, GB |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-26 |
| Decision Date | 1986-06-23 |