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510(k) K921569

Device
ORS-200
Applicant
MNLASE, INC.
510(k) number
K921569
Product code
JRM  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-09
Date received
1992-04-02
Regulation
862.2050
Classification name
Freezer
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRUCE HEYMANN
Address
11250 Roger Bacon Dr. #10 Reston VA US 22090 22090

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JRM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921568ORS-100Mnlase, Inc.1992-06-09
K921570ORS-300Mnlase, Inc.1992-06-09
K915427ORS-1000Mnlase, Inc.1992-01-07
K913777SELF-CONTAINED SURGICAL SLUSH FREEZERTaylor Corp.1991-09-25
K894006SANISERV SURGICAL SLUSH SYSTEMSaniserv, Inc.1989-11-03
K782077LANCER ICE CUBESherwood Medical Industries1979-04-03

Legacy Summary#

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FDA Review#

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