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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K932071
Device Name I.V. START KIT
Applicant
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Applicant Contact PATRICIA STAWARZ
Correspondent
Clinipad Corp.
66 High St.
P.O. Box 387
Guilford,  CT  06437
Correspondent Contact PATRICIA STAWARZ
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/28/1993
Decision Date 02/17/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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