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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 K854844
Device Name LS1000 SURGICAL ASPIRATOR II
Applicant
Engineering, Inc.
214 Lincoln Center Dr.
Foster City,  CA  94404
Applicant Contact ROBERT E LASH
Correspondent
Engineering, Inc.
214 Lincoln Center Dr.
Foster City,  CA  94404
Correspondent Contact ROBERT E LASH
Regulation Number878.4780
Classification Product Code
BTA  
Date Received12/04/1985
Decision Date 02/12/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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