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510(k) K913794

Device
SIMPEX INC. SURGICAL DRESSING
Applicant
SIMPEX, INC.
510(k) number
K913794
Product code
GDY  
Decision
Substantially Equivalent (SESE)
Decision date
1991-11-20
Date received
1991-08-23
Regulation
878.4450
Classification name
Gauze/sponge, Internal, X-ray Detectable
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
XI MEI
Address
801 Old York Rd. Suite 318 Jenkintown PA US 19046 19046

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.1997-12-17
K960236CPR LAP SPONGESCustom Pack Reliability1996-03-28
K955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.1996-02-22
K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.1995-12-19
K953830KENSORBKentron Health Care, Inc.1995-10-03
K953057CYLINDRICAL SPONGEMedical Perspectives Corp.1995-09-14
K953058ROUND STICK SPONGES, FLAT STICK SPONGESMedical Perspectives Corp.1995-09-14
K953059KITTNER DISSECTORMedical Perspectives Corp.1995-09-14
K953060ROSEBUD DISSECTORMedical Perspectives Corp.1995-09-14
K953062CHERRY DISSECTORMedical Perspectives Corp.1995-09-14
K953087CHERRY PIT DISSECTORMedical Perspectives Corp.1995-09-14
K953088TRIANGULAR SPONGESMedical Perspectives Corp.1995-09-14
K951911GAUZE, NONABSORABABLE, X-RAY DETECTABLE (INTERNAL SPONGE)Commercial Resources New Mexico, Ltd.1995-06-21
K950370ULTRACELL ORTHOPEDIC SPONGESUltracell Medical Technologies, Inc.1995-04-17
K950372ULTRACELL ORTHOPEDIC SPONGESUltracell Medical Technologies, Inc.1995-04-17

Legacy Summary#

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FDA Review#

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