SPREADER

Retractor

ORTHOPEDIC EQUIPMENT CO., INC.

The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Spreader.

Pre-market Notification Details

• Device ID: K781445
• 510k Number: K781445
• Device Name: SPREADER
• Classification: Retractor
• Applicant: ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GAD
• CFR Regulation Number: 878.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-08-23
• Decision Date: 1979-09-27