510(k) K924953

FLUID COOLED BONE SAW BLADE, 6000 SERIES by Boehringer Laboratories — Product Code GFA

K924953 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories for the device "FLUID COOLED BONE SAW BLADE, 6000 SERIES". The FDA issued a decision of Substantially Equivalent on January 21, 1993. The device falls under product code GFA (Blade, Saw, General & Plastic Surgery, Surgical), a Class I device regulated under 21 CFR 878.4820. Boehringer Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1993
Date Received
September 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Saw, General & Plastic Surgery, Surgical
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type