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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Reusable
510(k) Number K864193
Device Name GILBAUGH ASPIRATING BIOPSY SYRINGE/NEEDLE/GUN
Applicant
Gaw, Inc.
9155 SW Carnes Rd., #422
Portland,  OR  97225
Correspondent
Gaw, Inc.
9155 SW Carnes Rd., #422
Portland,  OR  97225
Regulation Number878.4800
Classification Product Code
GDM  
Date Received10/27/1986
Decision Date 11/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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