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510(k) K040729

SOLARIS D890 THERAPY PROBE by Dynatronics Corp. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2004
Date Received
March 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type

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  • K010948 — DYNATRON STS RX (May 15, 2001)
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  • K993919 — DYNATRON 900 (January 3, 2000)

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