The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Sfa Module.
Device ID | K896528 |
510k Number | K896528 |
Device Name: | SFA MODULE |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Contact | Robert S Cutler |
Correspondent | Robert S Cutler LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-16 |
Decision Date | 1990-01-26 |