510(k) K882493

ROD, IRRIGATOR SUPPORTING, TELESCOPING TYPE by Cambridge Technologies, Inc. — Product Code FOX

K882493 is an FDA 510(k) premarket notification submitted by Cambridge Technologies, Inc. for the device "ROD, IRRIGATOR SUPPORTING, TELESCOPING TYPE". The FDA issued a decision of Substantially Equivalent on July 19, 1988. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Cambridge Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1988
Date Received
June 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Infusion
Device Class
Class I
Regulation Number
880.6990
Review Panel
HO
Submission Type