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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
Recalls CDRH Recalls
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