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510(k) K002315

WISEBANDS SKIN CLOSURE DEVICE by Wisebands , Ltd. — Product Code MKY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2001
Date Received
July 31, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Skin Closure
Device Class
Class I
Regulation Number
878.4320
Review Panel
SU
Submission Type

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  • K962144 — PHOENIX ETE TISSUE EXTENSION SYSTEM (January 14, 1997)
  • K942425 — PROXIDERM (TENTATIVE) (November 4, 1994)
  • K942526 — SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM (July 19, 1994)