REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES

Arthroscope

STERILMED, INC.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Powered Arthroscopic Accessories.

Pre-market Notification Details

• Device ID: K012536
• 510k Number: K012536
• Device Name: REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
• Classification: Arthroscope
• Applicant: STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369
• Contact: Patrick Fleischhacker
• Correspondent: Patrick Fleischhacker; STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-07
• Decision Date: 2001-11-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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