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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 K921450
Device Name NON-INVASIVE TUBING
Applicant
SPECIALTY MEDICAL SALES, INC.
10 MANOR PKWY.
SALEM,  NH  03079
Applicant Contact MICHAEL MERCHANT
Correspondent
SPECIALTY MEDICAL SALES, INC.
10 MANOR PKWY.
SALEM,  NH  03079
Correspondent Contact MICHAEL MERCHANT
Regulation Number880.5440
Classification Product Code
FPK  
Date Received03/26/1992
Decision Date 02/05/1993
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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