510(k) Premarket Notification

• Device Classification Name: Operating Room Accessories Table Tray
• 510(k) Number: K860446
• Device Name: C ARM SURGICAL TABLE
• Applicant: MEDI-MECH, INC.; P.O. BOX 976; 1802 WEST SECOND STREET; THE DALLES, OR 97058
• Applicant Contact: BRUCE SCHWARTZ
• Correspondent: MEDI-MECH, INC.; P.O. BOX 976; 1802 WEST SECOND STREET; THE DALLES, OR 97058
• Correspondent Contact: BRUCE SCHWARTZ
• Regulation Number: 878.4950
• Classification Product Code: FWZ
• Date Received: 02/04/1986
• Decision Date: 03/10/1986
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General & Plastic Surgery
• 510k Review Panel: General & Plastic Surgery
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No