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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 K861521
Device Name UNIVERSAL DISPOSABLE INFUSION SET (CODE 0330)
Applicant
JUFREY MULTIMED CORP.
ATTN: IRA FISHMAN
2550 M STREET, N.W.
WASHINGTON,  DC  20037
Applicant Contact & BLOW
Correspondent
JUFREY MULTIMED CORP.
ATTN: IRA FISHMAN
2550 M STREET, N.W.
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
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