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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 (Compound, Powered)
510(k) Number K082637
Device Name CRANIAL PERFORATOR
Applicant
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact JIM BANIC
Correspondent
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact JIM BANIC
Regulation Number882.4305
Classification Product Code
HBF  
Date Received09/10/2008
Decision Date 12/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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