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510(k) K912116

Device
PRESSURE SORE MANAGEMENT KIT
Applicant
MEDICAL DEVICE INSPECTION CO., INC.
510(k) number
K912116
Product code
MCY  
Decision
Substantially Equivalent (SESE)
Decision date
1991-10-18
Date received
1991-05-14
Regulation
880.5075
Classification name
Wound Dressing Kit
Medical specialty
General Hospital
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ALAN P SCHWARTZ
Address
55 Northern Blvd., Suite 301 Great Neck NY US 11021 11021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MCY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970721DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEMJohnson & Johnson Medical, Inc.1997-03-21
K963719CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAYGrand Medical Products1996-11-27
K960585WOUND CARE COMPRESSION SYSTEM (WCCS)Suncoast Medical Products, Inc.1996-04-26
K952334DRESSING CHANGE TRAYBusse Hospital Disposables, Inc.1995-07-14
K951022CIRCULON SYSTEM STEP 1Convatec, A Division of E.R. Squibb & Sons1995-06-12
K951021CIRCULON SYSTEM STEP 2Convatec, A Division of E.R. Squibb & Sons1995-06-12
K951476E-PACK PROCEDURE KITSETHICON, Inc.1995-05-23
K931932DRESSING CHANGE TRAY-MODIFIEDMedsurg Industries, Inc.1993-08-27
K924690VARIOUS NON-STERILE CUSTOM TRAYS/KITSSurgipro Central, Inc.1993-07-16
K923905WOUND DRESSING KITKit Pak, Inc.1993-07-02
K925021TPN TRAY (STERILE)Customed, Inc.1993-06-07
K926063PER-Q-CATH DRESSING CHANGE TRAYGesco Intl., Inc.1993-06-07
K921347CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETERMedi-Flex Hospital Products, Inc.1993-01-08
K913480WOUND CARE TRAY ACatalina Biomedical Corp.1991-10-18
K912684HOME MEDICAL KIT - FOR LITTLE HURTSGreat West Medical Equipment, Inc.1991-10-15

Legacy Summary#

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FDA Review#

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