FDA 510(k) Application Details - K970131

Device Classification Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat

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510(K) Number K970131
Device Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant C.L. MCINTOSH & ASSOC., INC.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE, MD 20852 US
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Contact T. WHIT ATHEY, PH.D.
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Regulation Number 890.5300

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Classification Product Code IMI
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Date Received 01/14/1997
Decision Date 06/16/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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