510(k) K890252

BONE CURETTE by Kinetic Medical Products — Product Code HTF

K890252 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "BONE CURETTE". The FDA issued a decision of Substantially Equivalent on January 27, 1989. The device falls under product code HTF (Curette), a Class I device regulated under 21 CFR 878.4800. Kinetic Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1989
Date Received
January 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type