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MKY — System, Skin Closure Class I

FDA Device Classification

Classification Details

Product Code
MKY
Device Class
Class I
Regulation Number
878.4320
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K002315wisebandsWISEBANDS SKIN CLOSURE DEVICEMarch 15, 2001
K982439progressive surgical productsPROXIDERM, MODELS TN 460, TN 90 460, BK 460September 8, 1998
K970439progressive surgical productsPROXIDERM (D-460,D 90 460,D 180,460, PS 460)April 16, 1997
K962144phoenix biomedicalPHOENIX ETE TISSUE EXTENSION SYSTEMJanuary 14, 1997
K942425progressive surgical productsPROXIDERM (TENTATIVE)November 4, 1994
K942526life medical sciencesSURE-CLOSURE II 75MM SKIN STRETCHING SYSTEMJuly 19, 1994