The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Instrument Detergent Concentrate.
| Device ID | K933149 |
| 510k Number | K933149 |
| Device Name: | INSTRUMENT DETERGENT CONCENTRATE |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Alan I Becker |
| Correspondent | Alan I Becker NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-29 |
| Decision Date | 1994-02-16 |