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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 K924793
Device Name HAN-D-AID
Applicant
Salmon Ent.
#7 Hickory Heights
Hudson,  IL  61748
Applicant Contact CHARLES E BATTY
Correspondent
Salmon Ent.
#7 Hickory Heights
Hudson,  IL  61748
Correspondent Contact CHARLES E BATTY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/23/1992
Decision Date 10/19/1993
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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