EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL

Drills, Burrs, Trephines & Accessories (simple, Powered)

THE ANSPACH EFFORT, INC.

The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Emax 2 Plus System, Model Emax 2 Plus Motor, Emax 2 Console>firmware Upgrade, Emax 2 Fp Foot Pedal.

Pre-market Notification Details

• Device ID: K080802
• 510k Number: K080802
• Device Name: EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
• Classification: Drills, Burrs, Trephines & Accessories (simple, Powered)
• Applicant: THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410
• Contact: Jim Banic
• Correspondent: Jim Banic; THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410
• Product Code: HBE
• Subsequent Product Code: GEY
• Subsequent Product Code: HBF
• CFR Regulation Number: 882.4310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-21
• Decision Date: 2008-04-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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