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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 K173389
Device Name Rex Medical Aspiration Pump
Applicant
Rex Medical, L.P.
555 E. N. Ln.
Suite 5035
Conshohocken,  PA  19428
Applicant Contact Erich Bressler
Correspondent
Mdi Consultants, Inc.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact Susan Goldstein-Falk
Regulation Number878.4780
Classification Product Code
BTA  
Date Received10/30/2017
Decision Date 01/30/2018
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
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