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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K900134
Device Name BABY BOARDS IV SUPPORT ASSEMBLY
Applicant
Baby Boards, Inc.
1375 NE 200th Ter.
North Miami Beach,  FL  33179
Applicant Contact KENNETH R WRIGHT
Correspondent
Baby Boards, Inc.
1375 NE 200th Ter.
North Miami Beach,  FL  33179
Correspondent Contact KENNETH R WRIGHT
Regulation Number880.5210
Classification Product Code
KMK  
Date Received01/10/1990
Decision Date 07/09/1990
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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