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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K102403
Device Name SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
Applicant
Sam Medical Products
27350 SW 95th Ave. Suite 3038 Bldg. 30
Wilsonville,  OR  97070
Applicant Contact JACK N MCCUTCHEON
Correspondent
Sam Medical Products
27350 SW 95th Ave. Suite 3038 Bldg. 30
Wilsonville,  OR  97070
Correspondent Contact JACK N MCCUTCHEON
Regulation Number878.4020
Classification Product Code
NAD  
Date Received08/24/2010
Decision Date 03/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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