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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 K874157
Device Name LASE EVACUATOR/ASPIRATOR
Applicant
Lase, Inc.
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact PETER O SAFIR
Correspondent
Lase, Inc.
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact PETER O SAFIR
Regulation Number878.4780
Classification Product Code
BTA  
Date Received10/13/1987
Decision Date 03/21/1988
Decision Substantially Equivalent (SESE)
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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