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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Single Patient Use, Portable, Nonpowered
510(k) Number K896803
Device Name CLOSED WOUND RESERVOIR
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 Number878.4680
Classification Product Code
GCY  
Date Received12/01/1989
Decision Date 12/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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