FDA 510(k) Application Details - K011341

Device Classification Name Tubes, Gastrointestinal (And Accessories)

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510(K) Number K011341
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant LH MEDICAL PRODUCTS, INC.
301 EAST ARROW HWY., SUITE 104
SAN DIMAS, CA 91773 US
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Contact LONNIE HUTSON
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Regulation Number 876.5980

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Classification Product Code KNT
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Date Received 05/02/2001
Decision Date 09/21/2001
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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