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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K896561
Device Name EXTENSION SET
Applicant
Westmark, Sterile Packing Systems, Inc. (Sps)
1253 Ramona St. SE
Grand Rapids,  MI  49507
Applicant Contact SURY SHONEY
Correspondent
Westmark, Sterile Packing Systems, Inc. (Sps)
1253 Ramona St. SE
Grand Rapids,  MI  49507
Correspondent Contact SURY SHONEY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/17/1989
Decision Date 02/01/1990
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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