The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for Astotherm Ift 250, Ift 260, Astotube Various No..
| Device ID | K914364 |
| 510k Number | K914364 |
| Device Name: | ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO. |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | NORTH AMERICAN TECHNICAL SERVICES CORP. 407 EAST MAIN ST. P.O. BOX 347 Port Jefferson, NY 11777 |
| Contact | Richard Lanzillotto |
| Correspondent | Richard Lanzillotto NORTH AMERICAN TECHNICAL SERVICES CORP. 407 EAST MAIN ST. P.O. BOX 347 Port Jefferson, NY 11777 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-01 |
| Decision Date | 1992-09-10 |