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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Expander, Surgical, Skin Graft
510(k) Number K984448
Device Name BIRCOLL BALLOON DISSECTOR
Applicant
WELLS JOHNSON CO.
8000 SOUTH KOLB RD.
TUCSON,  AZ  85706
Applicant Contact KEN RODENBURG
Correspondent
WELLS JOHNSON CO.
8000 SOUTH KOLB RD.
TUCSON,  AZ  85706
Correspondent Contact KEN RODENBURG
Regulation Number878.4800
Classification Product Code
FZW  
Date Received12/14/1998
Decision Date 01/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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