MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM

Accessories, Cleaning, For Endoscope

MINNTECH CORP.

The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Medivators Dsd Edge Endoscope Reprocessing System.

Pre-market Notification Details

• Device ID: K092387
• 510k Number: K092387
• Device Name: MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Classification: Accessories, Cleaning, For Endoscope
• Applicant: MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447
• Contact: Richard M Ormsbee
• Correspondent: Richard M Ormsbee; MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447
• Product Code: FEB
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-05
• Decision Date: 2010-04-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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