510(k) K955805

DUAL SPRAY MINISPACER by Thayer Medical Corp. — Product Code CAF

K955805 is an FDA 510(k) premarket notification submitted by Thayer Medical Corp. for the device "DUAL SPRAY MINISPACER". The FDA issued a decision of Substantially Equivalent on March 21, 1996. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Thayer Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1996
Date Received
December 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type