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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K810918
Device Name ROLL-A-SET
Applicant
PRINCIPLE BUSINESS ENT.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PRINCIPLE BUSINESS ENT.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.6850
Classification Product Code
FRG  
Date Received04/06/1981
Decision Date 05/21/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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