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510(k) K954718

Device
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
Applicant
ELLMAN INTL., INC.
510(k) number
K954718
Product code
HEE  
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-29
Date received
1995-10-13
Regulation
884.5100
Classification name
Set, Anesthesia, Paracervical
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD C LANZILLOTTO
Address
30 Northport Rd. Sound Beach NY US 11789 11789

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HEE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGERocket Medical Plc2005-10-17
K021224ENDOCERVICAL BLOCK NEEDLEWallach Surgical Devices, Inc.2002-07-12
K000117AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLEAvid Medical, Inc.2000-04-13
K983897CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208GRi Mos. S.R.L.1999-02-01
K980238GYNEX EXTENDED REACH NEEDLEGynex Corp.1998-08-21
K973671ENDOCERVICAL BLOCK NEEDLEA & A Medical, Inc.1997-11-26
K910253LEEP REDIKITCooperSurgical, Inc.1991-04-18
K910252POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLECooperSurgical, Inc.1991-03-04

Legacy Summary#

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FDA Review#

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