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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 K896723
Device Name CLIP GUN WITH RANEY TYPE SCALP CLIPS
Applicant
Omni Medical Designs
19500 Middlebelt, Suite 333e
Livonia,  MI  48152
Applicant Contact ALAN TASH
Correspondent
Omni Medical Designs
19500 Middlebelt, Suite 333e
Livonia,  MI  48152
Correspondent Contact ALAN TASH
Regulation Number882.4150
Classification Product Code
HBO  
Date Received11/29/1989
Decision Date 03/23/1990
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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