510(k) K911606

BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES by Baxter Healthcare Corp — Product Code KDD

K911606 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES". The FDA issued a decision of Substantially Equivalent (kit) on July 9, 1991. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
July 9, 1991
Date Received
April 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Surgical Instrument, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type