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FDA 510(k) Application Details - K970994
Device Classification Name
Stylet For Catheter, Gastro-Urology
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510(K) Number
K970994
Device Name
Stylet For Catheter, Gastro-Urology
Applicant
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA, MN 55318 US
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Contact
KIM AVES
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Regulation Number
876.5130
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Classification Product Code
EZB
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Date Received
03/19/1997
Decision Date
03/25/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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