The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Polysonic Ultrasound Lotion.
| Device ID | K827296 |
| 510k Number | K827296 |
| Device Name: | POLYSONIC ULTRASOUND LOTION |
| Classification | Media, Coupling, Ultrasound |
| Applicant | PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-30 |
| Decision Date | 1982-04-16 |