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510(k) K950647

Device
ULTRACELL NEURO SPONGES
Applicant
ULTRACELL MEDICAL TECHNOLOGIES, INC.
510(k) number
K950647
Product code
HBA  
Decision
Substantially Equivalent (SESE)
Decision date
1995-08-15
Date received
1995-02-13
Regulation
882.4700
Classification name
Neurosurgical Paddie
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
GEORGE P KORTEWEG
Address
Post Office Box 609 Old Mystic CT US 06372 06372

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HBA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193346Codman Surgical Patties & StripsIntegra LifeSciences Corporation2020-11-20
K140369MEDLINE NEURO SPONGEMedline Industries, Inc.2014-09-26
K112598AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)American Surgical Company, LLC2013-06-20
K121822DELICOTAmerican Surgical Company, LLC2012-09-10
K073576NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGESHarod Enterprises, Inc.2008-02-22
K062406AESCULAP NEURO PATTIESAesculap, Inc.2006-09-15
K031008AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)Aesculap2003-05-09
K020736TRAATEK COTTONOID PATTIESTraatek, Inc.2002-06-03
K014268NORAPAD PLAIN; NORAPAD TAPerlei Medical, Inc.2002-03-27
K993019PACIFIC SURGICAL PATTIESV. Mueller Neuro/Spine2000-03-30
K973083ULTRACELL NEURO SPONGESUltracell Medical Technologies, Inc.1997-12-09
K962807AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGESAmerican Surgical Sponges1997-05-02
K970328ULTRACELL NEURO SPONGESUltracell Medical Technologies, Inc.1997-04-21
K914600NEUROLOGICAL SPONGEI M, Inc.1992-12-30
K923027NEURAY SURGICAL PATTIES AND STRIPSMartland Healthcare, Inc.1992-08-28

Legacy Summary#

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FDA Review#

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