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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K883474
Device Name THORACIC CATHETERS
Applicant
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
1253 RAMONA ST. S.E.
GRAND RAPIDS,  MI  49507
Applicant Contact TIM SAGERS
Correspondent
WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)
1253 RAMONA ST. S.E.
GRAND RAPIDS,  MI  49507
Correspondent Contact TIM SAGERS
Regulation Number878.4200
Classification Product Code
GBX  
Date Received08/16/1988
Decision Date 09/13/1988
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
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