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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K980003
Device Name M500-100 SHARPS CONTAINER
Applicant
Imagination Medical, Inc.
12855 Phillips Hwy.
Jacksonville,  FL  32256
Applicant Contact TIM WEIST
Correspondent
Imagination Medical, Inc.
12855 Phillips Hwy.
Jacksonville,  FL  32256
Correspondent Contact TIM WEIST
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/02/1998
Decision Date 03/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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