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510(k) K121123

BIOFUSIONARY BEBE by Rocky Mountain Biosystems, Inc. — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2014
Date Received
April 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

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