BABY QUASAR

Powered Light Based Non-laser Surgical Instrument

SILVER BAY, LLC

The following data is part of a premarket notification filed by Silver Bay, Llc with the FDA for Baby Quasar.

Pre-market Notification Details

• Device ID: K091467
• 510k Number: K091467
• Device Name: BABY QUASAR
• Classification: Powered Light Based Non-laser Surgical Instrument
• Applicant: SILVER BAY, LLC 333 MILFORD ROAD Deerfield, IL 60015
• Contact: Daniel Kamm, P.e.
• Correspondent: Daniel Kamm, P.e.; SILVER BAY, LLC 333 MILFORD ROAD Deerfield, IL 60015
• Product Code: ONE
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-18
• Decision Date: 2010-09-17
• Summary: summary