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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Adhesive For The Topical Approximation Of Skin
510(k) Number K101276
Device Name DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404
Applicant
Chemence Medical Products, Inc.
185 Bluegrass Valley Pkwy.
Suite 100
Alpharetta,  GA  30005 -2222
Applicant Contact PATRICIA LEHMAN
Correspondent
Chemence Medical Products, Inc.
185 Bluegrass Valley Pkwy.
Suite 100
Alpharetta,  GA  30005 -2222
Correspondent Contact PATRICIA LEHMAN
Regulation Number878.4010
Classification Product Code
MPN  
Date Received05/06/2010
Decision Date 07/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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