TURQUOISE

Gown, Surgical

ROSEBURG SA

The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Turquoise.

Pre-market Notification Details

• Device ID: K851559
• 510k Number: K851559
• Device Name: TURQUOISE
• Classification: Gown, Surgical
• Applicant: ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007
• Contact: Chamord
• Correspondent: Chamord; ROSEBURG SA 1054 31ST STREET, N.W. SUITE 120 CANAL SQUARE Washington, DC 20007
• Product Code: FYA
• CFR Regulation Number: 878.4040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-04-16
• Decision Date: 1985-04-30