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510(k) K902636

Device
LIPOGEN RHEUMELISA DSDNA ASSAY
Applicant
LIPOGEN, INC.
510(k) number
K902636
Product code
LRY  
Decision
Substantially Equivalent (SESE)
Decision date
1990-06-28
Date received
1990-06-14
Regulation
878.4800
Classification name
Punch, Surgical
Medical specialty
General & Plastic Surgery
Review panel
Immunology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MOKROS, M.S.
Address
10515 Research Dr. Knoxville TN US 37932 37932

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LRY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933516ACU-E PUNCHAcuderm, Inc.1994-03-24
K904869ELLIPSE PUNCHKramer Const1991-03-06
K896303BIOPSY PUNCHPremier Medical1990-02-13
K874356PIN PUNCHMed-Tool, Inc.1987-11-23
K874357TAPERED PUNCHMed-Tool, Inc.1987-11-23
K872388NAIL SETMed-Tool, Inc.1987-07-23

Legacy Summary#

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FDA Review#

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