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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name drills, burrs, trephines & accessories (simple, powered)
510(k) Number K183545
Device Name Anspach Helix Dissection Tools
Applicant
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens,  FL  33410
Applicant Contact Tamara J. West
Correspondent
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens,  FL  33410
Correspondent Contact Tamara J. West
Regulation Number882.4310
Classification Product Code
HBE  
Date Received12/20/2018
Decision Date 07/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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