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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solvent, Adhesive Tape
510(k) Number K923351
Device Name SKIN SUPPORT PREP PAD
Applicant
Coloplast Corp.
2150 New Market Pkwy.,
Suite 116
Marietta,  GA  30067
Applicant Contact LEE LEWIS
Correspondent
Coloplast Corp.
2150 New Market Pkwy.,
Suite 116
Marietta,  GA  30067
Correspondent Contact LEE LEWIS
Regulation Number878.4730
Classification Product Code
KOX  
Date Received07/08/1992
Decision Date 09/14/1992
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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