The following data is part of a premarket notification filed by Medical Polymers, Inc. with the FDA for Pds Ultraclean.
| Device ID | K934666 |
| 510k Number | K934666 |
| Device Name: | PDS ULTRACLEAN |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | MEDICAL POLYMERS, INC. 8920 BUSINESS PARK DR. SUITE 290 Austin, TX 78759 |
| Contact | Thomas Vanne |
| Correspondent | Thomas Vanne MEDICAL POLYMERS, INC. 8920 BUSINESS PARK DR. SUITE 290 Austin, TX 78759 |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-28 |
| Decision Date | 1994-04-15 |