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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K934688
Device Name STERILE DESIGN
Applicant
Sterile Design, Inc.
P.O. Box 12100
Oldsmar,  FL  34677
Applicant Contact JOYCE MOODY
Correspondent
Sterile Design, Inc.
P.O. Box 12100
Oldsmar,  FL  34677
Correspondent Contact JOYCE MOODY
Regulation Number878.4370
Classification Product Code
LRO  
Date Received09/30/1993
Decision Date 03/16/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General & Plastic Surgery
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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