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510(k) K881151

Device
MICROSCRAPE
Applicant
ORTHO PHARMACEUTICAL CORP.
510(k) number
K881151
Product code
LXK  
Decision
Substantially Equivalent (SESE)
Decision date
1988-04-06
Date received
1988-03-17
Regulation
878.4800
Classification name
Scrapper, Skin Specimen
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RUSSELL J HUME
Address
Rte. 202, P.O. Box 300 Raritan NJ US 08869 08869

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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