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510(k) K920104

Device
IDENTI LOOPS DEGANIA SILICONE
Applicant
PURITAS HEALTH CARE, INC.
510(k) number
K920104
Product code
DSS  
Decision
Substantially Equivalent (SESE)
Decision date
1992-04-20
Date received
1992-01-09
Regulation
870.3250
Classification name
Clip, Vascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ARCOVIO, JR.
Address
76 Stony Hill Village Brookfield CT US 06804 06804

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K983744MCAS (MODULAR CLIP APPLIER SYSTEM)Applied Medical Resources1999-01-21
K961333HEARTPORT MULTIFIRE CLIP APPLIERHeartport, Inc.1996-11-15
K920676RMI SOFCLAMPResearch Medical, Inc.1992-04-15
K914523CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COILCatheter Research C/O Burditt, Bowles & Radzius1992-01-10
K901303HORIZON SURGICAL LIGATING AND MARKING CLIPHorizon Surgical, Inc.1990-06-05
K883909SURGICAL SPRING CLIPSApplied Vascular Devices, Inc.1988-12-27
K771021AUTO-CLIPAxiom Medical, Inc.1977-06-14

Legacy Summary#

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FDA Review#

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