510(k) K073222

MODIFICATION TO:SPECIALTY NEEDLES by Busse Hospital Disposables, Inc. — Product Code BSP

K073222 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables, Inc. for the device "MODIFICATION TO:SPECIALTY NEEDLES". The FDA issued a decision of Substantially Equivalent on April 9, 2008. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Busse Hospital Disposables, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2008
Date Received
November 15, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type