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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Dermatome
510(k) Number K860925
Device Name DERMASPANDERE
Applicant
Mri Ventures, Inc.
425 Volker Blvd.
Kansas City,  MO  64110
Applicant Contact A. E VANDEGRIFT
Correspondent
Mri Ventures, Inc.
425 Volker Blvd.
Kansas City,  MO  64110
Correspondent Contact A. E VANDEGRIFT
Regulation Number878.4820
Classification Product Code
GFD  
Date Received03/11/1986
Decision Date 03/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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