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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, exhaust, surgical
510(k) Number K012991
Device Name NEPTUNE WASTE MANAGEMENT STSTEM
Original Applicant
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo,  MI  49001
Original Contact suzanne velazquez
Regulation Number878.5070
Classification Product Code
FYD  
Date Received09/06/2001
Decision Date 11/29/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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