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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name First Aid Kit With Drug
510(k) Number K891483
Device Name FIRST AID SURVIVAL KIT
Applicant
Elwyn, Inc.
Elwyn,  PA  19063
Applicant Contact A WASHINGTON
Correspondent
Elwyn, Inc.
Elwyn,  PA  19063
Correspondent Contact A WASHINGTON
Classification Product Code
LRR  
Date Received03/17/1989
Decision Date 05/11/1989
Decision Substantially Equivalent (SESE)
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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