SYRETTE

Burnisher, Operative

ORATEC CORP.

The following data is part of a premarket notification filed by Oratec Corp. with the FDA for Syrette.

Pre-market Notification Details

• Device ID: K881992
• 510k Number: K881992
• Device Name: SYRETTE
• Classification: Burnisher, Operative
• Applicant: ORATEC CORP. 485 SPRING PARK PLACE STE.100 Herndon, VA 22070
• Contact: Kelner, Phd
• Correspondent: Kelner, Phd; ORATEC CORP. 485 SPRING PARK PLACE STE.100 Herndon, VA 22070
• Product Code: EKJ
• CFR Regulation Number: 872.4565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-05-12
• Decision Date: 1988-07-26