510(k) K925387

LIBERATOR by Prentke Romich Co. — Product Code ILQ

K925387 is an FDA 510(k) premarket notification submitted by Prentke Romich Co. for the device "LIBERATOR". The FDA issued a decision of Substantially Equivalent on March 29, 1993. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. Prentke Romich Co. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1993
Date Received
October 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Powered
Device Class
Class II
Regulation Number
890.3710
Review Panel
PM
Submission Type