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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K934031
Device Name STERILE CENTRAL LINE DRESSING TRAY
Applicant
Surgipro, Inc.
P.O. Box 2010
Palm Florida,  FL  34682
Applicant Contact PATRICK J LAMB
Correspondent
Surgipro, Inc.
P.O. Box 2010
Palm Florida,  FL  34682
Correspondent Contact PATRICK J LAMB
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
LRO  
Date Received08/17/1993
Decision Date 03/01/1994
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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