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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 K831445
Device Name INFUSION SETS #'S 124 & 142 PERSONAL
Applicant
PACESETTER SYSTEMS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
PACESETTER SYSTEMS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/05/1983
Decision Date 09/12/1983
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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