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510(k) K970131

ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE by C.L. Mcintosh & Assoc., Inc. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1997
Date Received
January 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by C.L. Mcintosh & Assoc., Inc.

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  • K961725 — OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION (August 1, 1996)
  • K942227 — NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM (June 28, 1996)

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