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FDA 510(k) Application Details - K010702
Device Classification Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
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510(K) Number
K010702
Device Name
Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant
KMI KOLSTER METHODS, INC.
1170 N. GILBERT ST.
ANAHEIM, CA 92801 US
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Contact
ALWIN H KOLSTER
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Regulation Number
890.5300
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Classification Product Code
IMI
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More FDA Info for this Product Code
Date Received
03/08/2001
Decision Date
08/09/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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