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510(k) K914081

Device
ICAN COTTON RAYON BALLS
Applicant
ICN PHARMACEUTICALS, INC.
510(k) number
K914081
Product code
FRL  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-09
Date received
1991-09-11
Regulation
880.5300
Classification name
Fiber, Medical, Absorbent
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN J GOLDNER
Address
Icn Plz. 3300 Hyland Ave. Costa Mesa CA US 92626 92626

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FRL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121898STAY FRESH SKIN FOLD MANAGEMENT TEXTILEQuick-Med Technologies, Inc.2013-05-24
K110715INTERDRY SILVERMilliken Healthcare Products, LLC2011-11-04
K061615INTERDRY TEXTILE WITH SILVERMilliken Chemical2006-12-22
K931626CARAPACE STERILE COTTON BALLSCarapace, Inc.1993-12-02
K811990TRACH CLEANING TRAYAssociated Medical Products Co.1981-07-27
K810242UTENSIL & PROCEDURE TRAYSAmerican Hospital Supply Corp.1981-04-15
K800277MEDSPEC RAYON BALLSMedspec Corp.1980-03-12
K800248SURGITEK FOERSTER FACE LIFT BANDAGEMedical Engineering Corp.1980-02-19
K800249SURGITEK FOERSTER MAMMARY BANDAGEMedical Engineering Corp.1980-02-19
K792295SORBIESAmerican Hospital Supply Corp.1979-12-20
K792294BREAST PADAmerican Hospital Supply Corp.1979-12-11
K791167DEXIDE DISPOSABLE PREP PADDexide, Inc.1979-08-03
K780974BACILLUS PUMILUSUrol, Inc.1978-07-27
K771712CATHETER DRESSING CHANCE SETShield Laboratories, Inc.1977-10-13
K771551I.V. PREP & CARE KITJelco Laboratories1977-10-04

Legacy Summary#

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FDA Review#

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