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FDA 510(k) Application Details - K973590
Device Classification Name
Device, Thermal, Hemorrhoids
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510(K) Number
K973590
Device Name
Device, Thermal, Hemorrhoids
Applicant
A. STEIN - REGULATORY AFFAIRS CONSULTING
P.O.B. 454
GINOT SHOMRON 44853 IL
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Contact
AHAVA STEIN
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Regulation Number
000.0000
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Classification Product Code
LKX
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Date Received
09/22/1997
Decision Date
02/05/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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