GETINGE 700HC-E SERIES STEAM STERILIZER

Sterilizer, Steam

GETINGE SOURCING LLC

The following data is part of a premarket notification filed by Getinge Sourcing Llc with the FDA for Getinge 700hc-e Series Steam Sterilizer.

Pre-market Notification Details

• Device ID: K120441
• 510k Number: K120441
• Device Name: GETINGE 700HC-E SERIES STEAM STERILIZER
• Classification: Sterilizer, Steam
• Applicant: GETINGE SOURCING LLC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133
• Contact: Barb Smith
• Correspondent: Barb Smith; GETINGE SOURCING LLC 1777 EAST HENRIETTA RD. Rochester, NY 14623 -3133
• Product Code: FLE
• CFR Regulation Number: 880.6880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-13
• Decision Date: 2012-05-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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