The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for Hydrotone.
| Device ID | K974321 |
| 510k Number | K974321 |
| Device Name: | HYDROTONE |
| Classification | Bath, Hydro-massage |
| Applicant | NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1998-06-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HYDROTONE 88278898 5924582 Live/Registered |
WINBY ENTERPRISES LIMITED PARTNERSHIP II 2019-01-28 |
![]() HYDROTONE 88229916 not registered Live/Pending |
WINBY ENTERPRISES LIMITED PARTNERSHIP II 2018-12-14 |
![]() HYDROTONE 76582043 3052237 Dead/Cancelled |
WINBY ENTERPRISES LIMITED PARTNERSHIP II 2004-03-17 |
![]() HYDROTONE 74275798 1771124 Dead/Cancelled |
Innovative Health Products, Inc. 1992-05-14 |
![]() HYDROTONE 72057749 0689709 Dead/Cancelled |
GENERAL PRINTING INK CO. INC. 1958-08-25 |