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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K943206
Device Name VARIOUS TUBING
Applicant
Prn Services, Inc.
1551 E. Lincoln
Madison Heights,  MI  48071
Applicant Contact RENA K GOINS
Correspondent
Prn Services, Inc.
1551 E. Lincoln
Madison Heights,  MI  48071
Correspondent Contact RENA K GOINS
Regulation Number880.5440
Classification Product Code
FPK  
Date Received07/05/1994
Decision Date 03/09/1995
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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