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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Scalp
510(k) Number K944311
Device Name ACRA-CUT
Applicant
Acra Cut, Inc.
989 Main St.
Acton,  MA  01720
Applicant Contact RICHARD M ANDERSON
Correspondent
Acra Cut, Inc.
989 Main St.
Acton,  MA  01720
Correspondent Contact RICHARD M ANDERSON
Regulation Number882.4150
Classification Product Code
HBO  
Date Received09/02/1994
Decision Date 11/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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