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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perforator, Ear-Lobe
510(k) Number K860622
Device Name STUDEX EAR PIERCING GUNS
Applicant
Onyx Industries, Inc.
25311 S. Normandie Ave.
Harbor City,  CA  90710
Applicant Contact DANA MALTUN
Correspondent
Onyx Industries, Inc.
25311 S. Normandie Ave.
Harbor City,  CA  90710
Correspondent Contact DANA MALTUN
Regulation Number874.4420
Classification Product Code
JYS  
Date Received02/19/1986
Decision Date 10/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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