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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 K912612
Device Name SMOKE/ODOR EVACUATOR #757
Applicant
Olsen Electrosurgical, Inc.
2100 Meridian Park Blvd.
Concord,  CA  94520
Applicant Contact MARIA MURSELL
Correspondent
Olsen Electrosurgical, Inc.
2100 Meridian Park Blvd.
Concord,  CA  94520
Correspondent Contact MARIA MURSELL
Regulation Number878.5070
Classification Product Code
FYD  
Date Received06/12/1991
Decision Date 11/01/1991
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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