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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 K910733
Device Name MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE
Applicant
Medisystems Corp.
21st Floor
345 California St.
San Francisco,  CA  94104
Applicant Contact ALAN C HINTON
Correspondent
Medisystems Corp.
21st Floor
345 California St.
San Francisco,  CA  94104
Correspondent Contact ALAN C HINTON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/21/1991
Decision Date 06/06/1991
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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