The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for N/a.
Device ID | K970592 |
510k Number | K970592 |
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 |