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510(k) K002315

Device
WISEBANDS SKIN CLOSURE DEVICE
Applicant
WISEBANDS LTD.
510(k) number
K002315
Product code
MKY  
Decision
Substantially Equivalent (SESE)
Decision date
2001-03-15
Date received
2000-07-31
Regulation
878.4320
Classification name
System, Skin Closure
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARY PAGE
Address
P.O. Box 978 Ra'Anana IL 43107 43107

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MKY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K982439PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.1998-09-08
K970439PROXIDERM (D-460,D 90 460,D 180,460, PS 460)Progressive Surgical Products, Inc.1997-04-16
K962144PHOENIX ETE TISSUE EXTENSION SYSTEMPhoenix Biomedical Corp.1997-01-14
K942425PROXIDERM (TENTATIVE)Progressive Surgical Products, Inc.1994-11-04
K942526SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEMLife Medical Sciences, Inc.1994-07-19

Legacy Summary#

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FDA Review#

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