The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Sinuscan 102/sinusprint.
Device ID | K960421 |
510k Number | K960421 |
Device Name: | SINUSCAN 102/SINUSPRINT |
Classification | Ultrasound, Sinus |
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 | LWI |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-29 |
Decision Date | 1997-04-16 |
Summary: | summary |