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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 K925056
Device Name SAFESHARPE (TM) DISPOSAL SYSTEM
Applicant
Life Medical Technologies, Inc.
3649 W. 1987 S.
Salt Lake City,  UT  84104
Applicant Contact DAVID L VANGEISON
Correspondent
Life Medical Technologies, Inc.
3649 W. 1987 S.
Salt Lake City,  UT  84104
Correspondent Contact DAVID L VANGEISON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received10/06/1992
Decision Date 04/21/1995
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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