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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K850338
Device Name EMERGENCY ROOM PACK
Applicant
Marwood Medical, Inc.
Box 8712
Greensboro,  NC  27410
Applicant Contact DENISE RANCK
Correspondent
Marwood Medical, Inc.
Box 8712
Greensboro,  NC  27410
Correspondent Contact DENISE RANCK
Date Received01/28/1985
Decision Date 03/25/1985
Decision Substantially Equivalent (SESE)
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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