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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K922555
Device Name ENVIROMATE(TM) SMOKE EVACUATION SYSTEM
Applicant
Lase, Inc.
C/O Kleinfeld/Kaplan/Becker
1140 Nineteentlh St., NW
Washington,  DC  20036
Applicant Contact PETER O SAFIR
Correspondent
Lase, Inc.
C/O Kleinfeld/Kaplan/Becker
1140 Nineteentlh St., NW
Washington,  DC  20036
Correspondent Contact PETER O SAFIR
Regulation Number878.5070
Classification Product Code
FYD  
Date Received05/29/1992
Decision Date 01/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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