The following data is part of a premarket notification filed by Nats Corp. with the FDA for Hydrotone-thermal Capsule System.
| Device ID | K991184 |
| 510k Number | K991184 |
| Device Name: | HYDROTONE-THERMAL CAPSULE SYSTEM |
| Classification | Bath, Hydro-massage |
| Applicant | NATS CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto NATS CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-08 |
| Decision Date | 1999-06-23 |