The following data is part of a premarket notification filed by Amrex-zetron, Inc. with the FDA for Hydropulse(grossan);inflat Tube Mass.
| Device ID | K834507 |
| 510k Number | K834507 |
| Device Name: | HYDROPULSE(GROSSAN);INFLAT TUBE MASS |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | AMREX-ZETRON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-21 |
| Decision Date | 1984-01-17 |