510(k) K911606
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