The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Sam Sc.
Device ID | K913096 |
510k Number | K913096 |
Device Name: | SAM SC |
Classification | Nebulizer (direct Patient Interface) |
Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-12 |
Decision Date | 1992-12-03 |