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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 K911251
Device Name FLEX-IV
Applicant
Medway
2176 Hillsboro Rd.
Suite 120-362
Franklin,  TN  37064
Applicant Contact JAMES J CALLAWAY
Correspondent
Medway
2176 Hillsboro Rd.
Suite 120-362
Franklin,  TN  37064
Correspondent Contact JAMES J CALLAWAY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/21/1991
Decision Date 10/28/1991
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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