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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 K931634
Device Name VARIOUS KITS
Applicant
Polymint Industrial Co. , Ltd.
581 Conference Place
Golden,,  CO  80401
Applicant Contact ANDREW M REED
Correspondent
Polymint Industrial Co. , Ltd.
581 Conference Place
Golden,,  CO  80401
Correspondent Contact ANDREW M REED
Classification Product Code
LRR  
Date Received04/01/1993
Decision Date 11/30/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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