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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K841306
Device Name HEPARIN LOCK FLUSH SOLUTION USP KIT,100
Applicant
Solo Pak Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Solo Pak Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
LKB  
Date Received03/30/1984
Decision Date 06/04/1984
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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