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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Surgical, General & Plastic Surgery
510(k) Number K000932
Device Name ARACHNOPHLEBECTOMY NEEDLE
Applicant
Advanced Medical Products, Inc.
11902 Simpson Rd.
Clarksville,  MD  21029
Applicant Contact CHARLES H KYPER
Correspondent
Advanced Medical Products, Inc.
11902 Simpson Rd.
Clarksville,  MD  21029
Correspondent Contact CHARLES H KYPER
Regulation Number878.4800
Classification Product Code
GAH  
Date Received03/23/2000
Decision Date 05/17/2000
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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