510(k) K910117

REDDICK IRRIGATION/ASPIRATION SYSTEM by Ideal Medical, Inc. — Product Code GAA

K910117 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "REDDICK IRRIGATION/ASPIRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 19, 1991. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1991
Date Received
January 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type