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510(k) K841617

Device
STROVER HOOK
Applicant
PLASTAFIL, INC.
510(k) number
K841617
Product code
HCF  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-27
Date received
1984-04-19
Regulation
878.4800
Classification name
Instrument, Ligature Passing And Knot Tying
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150882Edwards Suture Fastening SystemEdwards Lifesciences, LLC2015-06-16
K931379MICROVASIVE INSURG LAPTIE SUTURE LIGATORBoston Scientific Corp1993-07-13
K851452VALTRAC PURSESTING DEVICEDavis & Geck, Inc.1985-06-12
K790577HEMORRHOIDAL LIGATORJ. Sklar Mfg. Co., Inc.1979-04-23

Legacy Summary#

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FDA Review#

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