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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 K981853
Device Name BONE INJECTION GUN (B.I.G.) DEVICE
Applicant
WAISMED LTD.
P.O.B. 454
GINOT SHOMRON,  IL 44853
Applicant Contact AHAVA STEIN
Correspondent
WAISMED LTD.
P.O.B. 454
GINOT SHOMRON,  IL 44853
Correspondent Contact AHAVA STEIN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received05/26/1998
Decision Date 11/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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