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510(k) K843890

Device
CUSTOM INSTRUMENT DRAPE
Applicant
LIFESTREAM INT'L, INC.
510(k) number
K843890
Product code
HMW  
Decision
Substantially Equivalent (SESE)
Decision date
1984-10-26
Date received
1984-10-02
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
RICK WILBORN
Address
525 Julie Rivers Dr. Suite 100 Sugar Land TX US 77478 77478

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
K911040INVOTEC MICROSCOPE DRAPEInvotec International, Inc.1991-06-03
K902763STERILE INSTRUMENT DRAPENorth American Sterilization & Packaging Co.1990-09-20
K902851MICROSCOPE DRAPEMedical Technique Instruments, Inc.1990-09-10

Legacy Summary#

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FDA Review#

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