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FDA 510(k) Application Details - K962259
Device Classification Name
Colonic Irrigation System
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510(K) Number
K962259
Device Name
Colonic Irrigation System
Applicant
TILLER MIND BODY, INC.
2204 N.W. LOOP 410 #2C
SAN ANTONIO, TX 78230 US
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Contact
JERI TILLER
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Regulation Number
876.5220
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Classification Product Code
KPL
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More FDA Info for this Product Code
Date Received
06/12/1996
Decision Date
08/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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