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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 K140179
Device Name EASY GO VAC
Applicant
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Applicant Contact JAMES PARKER
Correspondent
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Correspondent Contact JAMES PARKER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received01/24/2014
Decision Date 04/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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