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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scrapper, Skin Specimen
510(k) Number K881151
Device Name MICROSCRAPE
Applicant
Ortho Pharmaceutical Corp.
Route 202, P.O. Box 300
Raritan,  NJ  08869
Applicant Contact RUSSELL J HUME
Correspondent
Ortho Pharmaceutical Corp.
Route 202, P.O. Box 300
Raritan,  NJ  08869
Correspondent Contact RUSSELL J HUME
Regulation Number878.4800
Classification Product Code
LXK  
Date Received03/17/1988
Decision Date 04/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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