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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 K873848
Device Name RETROBULBAR NEEDLE
Applicant
Healthtek, Inc.
870 Gold Flat Rd.
P.O. Box 1130
Nevada City,  CA  95959
Applicant Contact CLIFFORD A TYNER
Correspondent
Healthtek, Inc.
870 Gold Flat Rd.
P.O. Box 1130
Nevada City,  CA  95959
Correspondent Contact CLIFFORD A TYNER
Regulation Number878.4800
Classification Product Code
GDM  
Date Received09/22/1987
Decision Date 10/23/1987
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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