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510(k) K921775

Device
SPYROFLEX WOUND CLOSURES
Applicant
POLYMINT INDUSTRIAL CO. LTD.
510(k) number
K921775
Product code
FPX  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-19
Date received
1992-04-10
Regulation
880.5240
Classification name
Strip, Adhesive, Closure, Skin
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANDREW M REED
Address
4080 Youngfield St. Wheat Ridge CO US 80033 80033

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FPX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970441K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTHMedi-Flex Hospital Products, Inc.1997-05-09
K952947DELPORE SKIN CLOSUREBitco Intl.1995-07-24
K952702DERMA SEALTtl Medical1995-06-28
K946321BIOSTRIP STERILE WOUND CLOSURE STRIPCornelia Damsky, Inc.1995-01-12
K931005DUKAL SKIN CLOSURE STRIPDukal Corp.1993-07-14
K894802AWC BUTTERFLY WOUND CLOSURESAmerican White Cross, Inc.1990-01-31
K894205TECNOL SILK STRIPTecnol New Jersey Wound Care, Inc.1989-07-25
K874813OMED WOUND CLOSURE STRIPSOxboro Medical Intl., Inc.1988-01-29
K840945SKIN CLOSUREGainor Medical1984-10-31
K842621SUTURE STRIPGenetic Laboratories, Inc.1984-10-25
K833258SKIN TECH. SURGI-STRIPSLee Tec Corp.1984-01-25
K833083DERMA STRIP-TM SKIN CLOSURESHowmedica Corp.1983-12-30
K831438ELASTOPLASTBeiersdorf, Inc.1983-11-25
K831439ELASTOPLAST T.P.N.Beiersdorf, Inc.1983-09-29
K821763SHUR-STRIP APPLICATORShur Medical Corp.1982-06-23

Legacy Summary#

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FDA Review#

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