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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 K971749
Device Name EASYGO ASPIRATOR
Applicant
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Applicant Contact CONLEY WALLACE
Correspondent
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Correspondent Contact CONLEY WALLACE
Regulation Number878.4780
Classification Product Code
BTA  
Date Received05/12/1997
Decision Date 04/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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