FDA 510(k) Application Details - K973732

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

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510(K) Number K973732
Device Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Applicant PTI
6700 SW TOPEKA BLVD.
FORBES FIELD, BLDG. 140
TOPEKA, KS 66619 US
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Contact CHRIS C ASTEL
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Regulation Number 890.5290

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Classification Product Code IMJ
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Date Received 09/30/1997
Decision Date 01/23/1998
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

FDA Source Information for K973732


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