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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K902135
Device Name PERCUTANEOUS INTRODUCER KIT
Applicant
DEVICE LABS, INC.
3 INDUSTRIAL PARK RD.
MEDWAY,  MA  02053
Applicant Contact ELTON M TUCKER
Correspondent
DEVICE LABS, INC.
3 INDUSTRIAL PARK RD.
MEDWAY,  MA  02053
Correspondent Contact ELTON M TUCKER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/10/1990
Decision Date 08/01/1990
Decision Substantially Equivalent - Kit (SESK)
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
Recalls CDRH Recalls
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