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510(k) K201877

Device
OtoSet- Ear Cleaning System
Applicant
SafKan, Inc.
510(k) number
K201877
Product code
KYZ  
Decision
Substantially Equivalent (SESE)
Decision date
2020-11-05
Date received
2020-07-07
Regulation
880.6960
Classification name
Syringe, Irrigating (non Dental)
Medical specialty
General Hospital
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sahil Diwan
Address
1665 E 18th St. #205 Tucson AZ US 85719 85719

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KYZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.2011-03-15
K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.2009-08-17
K050797TISSU-TRANSShippert Medical Technologies Corp.2005-07-13
K991254QS DELIVERY SYSTEMSub-Q, Inc.1999-08-23
K982435IRRIGATION SYRINGE KITSub-Q, Inc.1998-11-06
K974288ZEROWET SPLASHIELDZerowet, Inc.1998-01-29
K964833RMI DUAL FLUID IRRIGATING SYRINGEResearch Medical, Inc.1997-02-19
K960725MARPP PRESSURE MONITORING SYSTEMParadigm Medical, Inc.1996-07-15
K960212CPR IRRIGATION TRAYCustom Pack Reliability1996-04-01
K952407REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATERContour Fabricators of Florida, Inc.1995-08-07
K952406REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTIONContour Fabricators of Florida, Inc.1995-08-07
K933171INMAN IRRIGATION TAPERED PROBEInman Medical Corp.1994-04-29
K940371SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIPMicromedics, Inc.1994-04-06
K930610TALC DISPENSER SYRINGENusurg, Inc.1993-11-04
K924517AVITENE DISPENSER SYRINGENusurg, Inc.1993-10-27

Legacy Summary#

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FDA Review#

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