The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for N/a.
| Device ID | K970590 |
| 510k Number | K970590 |
| Device Name: | N/A |
| Classification | Lamp, Infrared, Therapeutic Heating |
| 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 | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-06-13 |