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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Bacterial, Breathing-Circuit
510(k) Number K945543
Device Name GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE
Applicant
Intersect Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55424
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Intersect Medical Products, Inc.
4503 Moorland Ave.
Minneapolis,  MN  55424
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number868.5260
Classification Product Code
CAH  
Subsequent Product Code
BTT  
Date Received11/14/1994
Decision Date 11/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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