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510(k) K100517

Device
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
Applicant
INSTRUMED INTERNATIONAL, INC.
510(k) number
K100517
Product code
HDA  
Decision
Substantially Equivalent (SESE)
Decision date
2010-04-29
Date received
2010-02-23
Regulation
884.4400
Classification name
Forceps, Obstetrical
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL MASSONG
Address
626 Cooper Ct. Schaumburg IL US 60173 60173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HDA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K092827DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XXDimeda Instrumente GmbH2010-01-08
K013747TEKNO-MEDICAL OBSTETRICAL FORCEPSTekno Medical Optik-Chirurgie GmbH & Co.2002-02-11
K951529V. MUELLER OBSTETRICAL (OB) FORCEPSBaxter Healthcare Corp1995-08-04
K914552CMI VACUUM PUMPColumbia Medical & Surgical, Inc.1993-09-07
K905583ILC FORCEPS PADSInman Liebelt Corp.1991-04-12
K903205AUTO SUTURE(R) ENDOSCOPIC CLAMPUnited States Surgical, A Division of Tyco Healthc1990-10-11
K890385MIDWIFERY/OBSTETRICAL FORCEPSKinetic Medical Products1989-03-01
K851883SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420The Huxley Instrument Corp.1985-05-09
K771106FORCEPS, OB, NON-COMPRESSIVEZeppelin Medizinlechnik GmbH1977-07-01

Legacy Summary#

summary

FDA Review#

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