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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable
510(k) Number K802248
Device Name DISARP ORIGINAL
Applicant
UNOPLAST A/S
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
UNOPLAST A/S
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4495
Classification Product Code
GAO  
Date Received09/16/1980
Decision Date 09/26/1980
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
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