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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K090445
Device Name ATMOS C361/C451 SUCTION PUMP
Applicant
Atmos, Inc.
3717 Huckleberry Rd.
Allentown,  PA  18104
Applicant Contact MARCO SCHLEGEL
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number878.4780
Classification Product Code
BTA  
Date Received02/20/2009
Decision Date 02/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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