FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058

Electrode, Cutaneous

LORENZ BIOTECH S.P.A.

The following data is part of a premarket notification filed by Lorenz Biotech S.p.a. with the FDA for Frems Ssc Disposable Foam Electrodes, Model 800-000-057; Frems Ssc Disposable Non-woven Electrodes, Model 800-000-058.

Pre-market Notification Details

• Device ID: K080902
• 510k Number: K080902
• Device Name: FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058
• Classification: Electrode, Cutaneous
• Applicant: LORENZ BIOTECH S.P.A. 49 PLAIN STREET North Attleboro, MA 02760
• Contact: Rosina Robinson
• Correspondent: Rosina Robinson; LORENZ BIOTECH S.P.A. 49 PLAIN STREET North Attleboro, MA 02760
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-02
• Decision Date: 2008-06-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08055765540010	K080902	000