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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K861520
Device Name UNIVERSAL DISPOSABLE INFUSION SET (CODE 0205)
Applicant
Jufrey Multimed Corp.
Attn: Ira Fishman
2550 M St., NW
Washington,  DC  20037
Applicant Contact & BLOW
Correspondent
Jufrey Multimed Corp.
Attn: Ira Fishman
2550 M St., NW
Washington,  DC  20037
Correspondent Contact & BLOW
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/23/1986
Decision Date 05/27/1986
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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