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510(k) K951064

Device
DISPOSABLE WOUND MEASURE GUIDE, PLASTIC, PROTECTOR, WOUND, PLASTIC
Applicant
S-E SALES & DISTRIBUTION, INC.
510(k) number
K951064
Product code
FTY  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-19
Date received
1995-03-08
Regulation
878.4800
Classification name
Tape, Measuring, Rulers And Calipers
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
RICHARD J FRANK
Address
P.O. Box 131 Poultney VT US 05764 05764

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FTY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K160501Noxilizer Surgical RulerNoxilizer, Inc.2016-05-26
K934930OLYMPIC AUTO-LENGTHOlympic Medical Corp.1993-12-29
K932112OLYMPIC INFA-LENGTHOlympic Medical Corp.1993-07-22
K883485STRYKER PRESSURE MONITOR SYSTEMStryker Corp.1988-09-13
K880441PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.Plane Iii, Inc.1988-02-18
K874352TUMORIMETERCancer Technologies, Inc.1987-11-23
K873470TEMPLATECox-Uphuff Intl.1987-09-08
K872319LN 100 BREAST MARKERInstrumentation Industries, Inc.1987-08-11
K863409KUNDIN WOUND GAUGEJane I. Kundin1986-09-29
K862576PS2 BRAND FACIAL SYMMETRY GUIDE (LEE DESIGN)Professional Services For Surgeons, Ltd.1986-07-15
K860912PS2 BRAND MAMMAPLASTYProfessional Services For Surgeons, Ltd.1986-03-24
K854892RULEREuro-Med Intl.1985-12-24
K840651MOLE-MARKERNotation Systems, Inc.1984-03-12
K832899ZIMMER OSSIMETERZimmer, Inc.1983-10-14
K831041SAGITTAL KNEE TESTEROrthopedic Systems, Inc.1983-06-24

Legacy Summary#

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FDA Review#

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