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510(k) K121814

Device
ENCORE TONGUE SUSPENSION SYSTEM
Applicant
SIESTA MEDICAL, INC.
510(k) number
K121814
Product code
ORY  
Decision
Substantially Equivalent (SESE)
Decision date
2012-11-07
Date received
2012-06-20
Regulation
872.5570
Classification name
Prelude Tongue Suspension System
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL KOLBER
Address
101 Church St., Suite 3 Los Gatos CA US 95030 95030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ORY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213159Encore SystemSiesta Medical, Inc.2021-12-22
K201238Encore SystemSiesta Medical, Inc.2020-10-02
K183310Encore SystemSiesta Medical, Inc.2019-05-09
K133680ENCORE SYSTEMSiesta Medical, Inc.2014-03-26
K121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KITSiesta Medical, Inc.2012-12-06
K111179ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMENSiesta Medical, Inc.2011-07-01
K110127PRELUDE III TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.2011-04-08
K103179PRELUDE II TOUNGE SUSPENSION SYSTEMSiesta Medical, Inc.2010-12-20
K101060SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.2010-07-08

Legacy Summary#

summary

FDA Review#

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