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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 K860678
Device Name J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS
Applicant
Jay Kenny Templeton
628 W. N. Market Blvd.,
Suite 1
Sacremento,  CA  95834
Applicant Contact KEN TEMPLETON
Correspondent
Jay Kenny Templeton
628 W. N. Market Blvd.,
Suite 1
Sacremento,  CA  95834
Correspondent Contact KEN TEMPLETON
Regulation Number874.4420
Classification Product Code
JYS  
Date Received02/25/1986
Decision Date 08/29/1986
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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