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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K040208
Device Name NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
Applicant
Tz Medical, Inc.
7272 SW Durham Rd., #800
Portland,  OR  97224
Applicant Contact MADALYN DUNCAN
Correspondent
Tz Medical, Inc.
7272 SW Durham Rd., #800
Portland,  OR  97224
Correspondent Contact MADALYN DUNCAN
Classification Product Code
QSY  
Date Received01/30/2004
Decision Date 05/11/2004
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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