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510(k) K962144

Device
PHOENIX ETE TISSUE EXTENSION SYSTEM
Applicant
PHOENIX BIOMEDICAL CORP.
510(k) number
K962144
Product code
MKY  
Decision
Substantially Equivalent (SESE)
Decision date
1997-01-14
Date received
1996-06-03
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
HORACE J WILMER
Address
P.O. Box 80390 Norristown PA US 19403 19403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MKY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K002315WISEBANDS SKIN CLOSURE DEVICEWisebands , Ltd.2001-03-15
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
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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