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510(k) K131745

Device
BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
Applicant
HELIX MEDICAL, LLC
510(k) number
K131745
Product code
LFB  
Decision
Substantially Equivalent (SESE)
Decision date
2013-09-17
Date received
2013-06-13
Regulation
510(k) Premarket Notification
Classification name
Button, Nasal Septal
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Ear Nose & Throat
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
PAUL DRYDEN
Address
1110 Mark Ave. Carpinteria CA US 93013 93013

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LFB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K013696SILMED NASAL SEPTAL BUTTONSilmed, Inc.2001-11-28
K982667MICROMEDICS NASAL SEPTAL BUTTONMicromedics, Inc.1998-11-24
K972060NASAL SEPTAL BUTTONBoston Medical Products, Inc.1997-07-03
K920994HOOD NASAL SEPTAL BUTTONHood Laboratories1992-05-15
K901366INVOTEC SEPTAL BUTTONInvotec International, Inc.1990-06-14
K871072OMEGA NASAL SEPTAL BUTTONOmega Silicone, Inc.1987-06-08
K871200CUI NASAL SEPTUM BUTTONCox-Uphuff Intl.1987-04-15
K862497MICROTEK SEPTAL BUTTONMicrotek Medical, Inc.1986-07-14
K822637NASAL SEPTAL BUTTONSAbco Dealers, Inc.1982-09-28
K781529SEPTAL BUTTONXomed, Inc.1978-10-17

Legacy Summary#

summary

FDA Review#

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