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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 K010038
Device Name NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE
Applicant
Cambridge Marketing, Inc.
P.O. 306
813 Ela Ave.
Waterford,  WI  53185
Applicant Contact JOSEPH B DUNN
Correspondent
Cambridge Marketing, Inc.
P.O. 306
813 Ela Ave.
Waterford,  WI  53185
Correspondent Contact JOSEPH B DUNN
Regulation Number880.5570
Classification Product Code
FMI  
Date Received01/05/2001
Decision Date 01/24/2001
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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