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510(k) K946015

Device
IVALON EXTERNAL SPONGE
Applicant
IVALON
510(k) number
K946015
Product code
NAB  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-27
Date received
1994-12-09
Regulation
878.4014
Classification name
Gauze / Sponge,nonresorbable For External Use
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ELIZABETH J MELARAGNO
Address
5374 Linda Vista Rd., Suite C San Diego CA US 92110 92110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NAB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940755ISOLYER (4X4, 8PLY)Isolyer Co.1994-05-02
K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.1993-06-24
K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.1993-04-08
K926072K-BAND AND K-CREPEParema , Ltd.1993-03-19
K915591STERILE GAUZE PADSEagle Medical, Inc.1993-01-27
K924650GAUZE SPONGESDav-Mar Medical Products, Inc.1993-01-11
K923602ABSORBENT PAD -- MODIFICATIONWinfield Laboratories, Inc.1992-12-07
K923115CLINISORBHermitage Hospital Products, Inc.1992-11-23
K923116COMBINE II WETPROOF PADHermitage Hospital Products, Inc.1992-10-06
K923378USP TYPE VII GAUZE SPONGESE.W.A., Ltd.1992-10-06
K923846BURN DRESSINGMedical Action Industries, Inc.1992-09-11
K915821MULTIPLE STERILE GAUZE BANDAGE ROLLS, VARI SIZESKerma Medical Products, Inc.1992-05-29
K920282PRE-CUT TRACHEOSTOMY DRESSING STERILE, DISPOSABLETrinity Laboratories, Inc.1992-05-29
K921227TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGECourtaulds Fibers, Inc.1992-05-29
K920269EZ GAUZE SPONGECal West Trading Co.1992-04-22

Legacy Summary#

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FDA Review#

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