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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 K923799
Device Name SMOKE EATER
Applicant
Nordex Medical Corp.
3417 Roger B. Chaffee Blvd.,
Suite 309
Grand Rapids,  MI  49548
Applicant Contact JAY T BAATZ
Correspondent
Nordex Medical Corp.
3417 Roger B. Chaffee Blvd.,
Suite 309
Grand Rapids,  MI  49548
Correspondent Contact JAY T BAATZ
Regulation Number878.5070
Classification Product Code
FYD  
Date Received07/29/1992
Decision Date 01/29/1993
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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