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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 K922845
Device Name BASIC DRESSING CHANGE TRAY SMP 102A
Applicant
Specialty Medical Products Co.
1604 Merrill Dr.
Suite D
Little Rock,  AR  72212
Applicant Contact JOHN LAMB
Correspondent
Specialty Medical Products Co.
1604 Merrill Dr.
Suite D
Little Rock,  AR  72212
Correspondent Contact JOHN LAMB
Regulation Number880.6850
Classification Product Code
FRG  
Date Received06/12/1992
Decision Date 12/29/1992
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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