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FDA 510(k) Application Details - K970590
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K970590
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
NORTH AMERICAN TECHNICAL SERVICES CORP.
30 NORTHPORT RD.
SOUND BEACH, NY 11789-1734 US
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Contact
RICHARD C LANZILLOTTO
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Regulation Number
890.5500
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Classification Product Code
ILY
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More FDA Info for this Product Code
Date Received
02/18/1997
Decision Date
06/13/1997
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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