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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, external aesthetic restoration, used with adhesive
510(k) Number K864786
Device Name PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
Applicant
COLOPLAST CORP.
2150 NEW MARKET PARKWAY,
SUITE 116
MARIETTA,  GA  30067
Applicant Contact THOMAS B TAYLOR
Correspondent
COLOPLAST CORP.
2150 NEW MARKET PARKWAY,
SUITE 116
MARIETTA,  GA  30067
Correspondent Contact THOMAS B TAYLOR
Regulation Number878.3800
Classification Product Code
GBI  
Date Received12/08/1986
Decision Date 01/08/1987
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
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