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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K882114
Device Name AMISCO U-100 INSULIN SYRINGE
Applicant
American Intl. Medical Supply Co.
3762 S. 150 E.
Salt Lake City,  UT  84115
Applicant Contact CHARLES B CHENEY
Correspondent
American Intl. Medical Supply Co.
3762 S. 150 E.
Salt Lake City,  UT  84115
Correspondent Contact CHARLES B CHENEY
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/18/1988
Decision Date 08/23/1988
Decision Substantially Equivalent (SESE)
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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