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510(k) K911040

Device
INVOTEC MICROSCOPE DRAPE
Applicant
INVOTEC INTERNATIONAL, INC.
510(k) number
K911040
Product code
HMW  
Decision
Substantially Equivalent (SESE)
Decision date
1991-06-03
Date received
1991-03-08
Regulation
878.4370
Classification name
Drape, Microscope, Ophthalmic
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY L AULL
Address
11330-1st. John'S Industrial Pkwy. Jacksonville FL US 32216 32216

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HMW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K902763STERILE INSTRUMENT DRAPENorth American Sterilization & Packaging Co.1990-09-20
K902851MICROSCOPE DRAPEMedical Technique Instruments, Inc.1990-09-10
K843890CUSTOM INSTRUMENT DRAPELifestream Int'L, Inc.1984-10-26

Legacy Summary#

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FDA Review#

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