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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 K960064
Device Name TEMNO ACHIEVE BIOPSY NEEDLE
Applicant
BAUER MEDICAL, INC.
13191 56TH COURT
SUITE 106
CLEARWATER,  FL  34620
Applicant Contact PAT LAMB
Correspondent
BAUER MEDICAL, INC.
13191 56TH COURT
SUITE 106
CLEARWATER,  FL  34620
Correspondent Contact PAT LAMB
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/05/1996
Decision Date 04/05/1996
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
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