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510(k) K810251

Device
SYRINGE, ENT
Applicant
MEGAPLAST, INC.
510(k) number
K810251
Product code
KYZ  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-11
Date received
1981-01-29
Regulation
880.6960
Classification name
Syringe, Irrigating (non Dental)
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KYZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201877OtoSet- Ear Cleaning SystemSafkan, Inc.2020-11-05
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
K952406REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTIONContour Fabricators of Florida, Inc.1995-08-07
K952407REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATERContour 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

Legacy Summary#

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FDA Review#

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