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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K881957
Device Name HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT
Applicant
N-S Medical Products
4435 SW 35th Terrace
Suite 360
Gainesville,  FL  32608
Applicant Contact KEITH L STAHL
Correspondent
N-S Medical Products
4435 SW 35th Terrace
Suite 360
Gainesville,  FL  32608
Correspondent Contact KEITH L STAHL
Regulation Number876.1075
Classification Product Code
KNW  
Date Received05/10/1988
Decision Date 05/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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