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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 K861081
Device Name DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH
Applicant
Perkins & Perkins, Inc.
8806 Liberty Ln.
Potomac,  MD  20854
Applicant Contact JERRI BARDEN-PERKINS
Correspondent
Perkins & Perkins, Inc.
8806 Liberty Ln.
Potomac,  MD  20854
Correspondent Contact JERRI BARDEN-PERKINS
Regulation Number880.5570
Classification Product Code
FMI  
Date Received03/21/1986
Decision Date 04/09/1986
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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