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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K912351
Device Name VARIOUS STERILE CUSTOM DRESSING TRAYS & KITS
Applicant
Surgipro, Inc.
C/O Patrick J.Lamb
P.O.Box 431
Palm Harbor,  FL  34683
Applicant Contact PATRICK LAMB
Correspondent
Surgipro, Inc.
C/O Patrick J.Lamb
P.O.Box 431
Palm Harbor,  FL  34683
Correspondent Contact PATRICK LAMB
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/28/1991
Decision Date 06/17/1993
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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