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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name I.V. Start Kit
510(k) Number K922533
Device Name IV START KIT CUSTOM SMP # A-Z
Applicant
Specialty Medical Products Co.
1604 Merrill Dr.
Suite D
Little Rock,  AK  72212
Applicant Contact JOHN LAMB
Correspondent
Specialty Medical Products Co.
1604 Merrill Dr.
Suite D
Little Rock,  AK  72212
Correspondent Contact JOHN LAMB
Regulation Number880.5200
Classification Product Code
LRS  
Date Received05/28/1992
Decision Date 03/23/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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