510(k) K193192

Tamper Evident Cap by International Medical Industries, Inc. — Product Code FMF

K193192 is an FDA 510(k) premarket notification submitted by International Medical Industries, Inc. for the device "Tamper Evident Cap". The FDA issued a decision of Substantially Equivalent on January 31, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. International Medical Industries, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2020
Date Received
November 19, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type