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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 K911597
Device Name THE NEEDLE NABBER
Applicant
J. Simmons Instrument , Ltd.
Independence Ct. Rd. 9
Brewster,  NY  10509
Applicant Contact JOHN SIMMONS
Correspondent
J. Simmons Instrument , Ltd.
Independence Ct. Rd. 9
Brewster,  NY  10509
Correspondent Contact JOHN SIMMONS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/09/1991
Decision Date 07/26/1991
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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