SKILCRAFT

Kit, Surgical Instrument, Disposable

PENNSYLVANIA ASSOCIATION FOR THE BLIND

The following data is part of a premarket notification filed by Pennsylvania Association For The Blind with the FDA for Skilcraft.

Pre-market Notification Details

• Device ID: K880785
• 510k Number: K880785
• Device Name: SKILCRAFT
• Classification: Kit, Surgical Instrument, Disposable
• Applicant: PENNSYLVANIA ASSOCIATION FOR THE BLIND WASHINGTON-GREEN COUNTY BRANCH 566 EAST MAIDEN STREET Washington, PA 15301
• Contact: Pilgun, Ii
• Correspondent: Pilgun, Ii; PENNSYLVANIA ASSOCIATION FOR THE BLIND WASHINGTON-GREEN COUNTY BRANCH 566 EAST MAIDEN STREET Washington, PA 15301
• Product Code: KDD
• CFR Regulation Number: 878.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-02-26
• Decision Date: 1988-03-11