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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K924690
Device Name VARIOUS NON-STERILE CUSTOM TRAYS/KITS
Applicant
Surgipro Central, Inc.
C/O Pat Lamb & Associates
P.O. Box 431
Tarpon Springs,  FL  34689
Applicant Contact PATRICK J LAMB
Correspondent
Surgipro Central, Inc.
C/O Pat Lamb & Associates
P.O. Box 431
Tarpon Springs,  FL  34689
Correspondent Contact PATRICK J LAMB
Regulation Number880.5075
Classification Product Code
MCY  
Date Received09/17/1992
Decision Date 07/16/1993
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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