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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 K001082
Device Name STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
Applicant
Stackhouse, Inc.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Applicant Contact TOM GUTIERREZ
Correspondent
Stackhouse, Inc.
1100 Bird Center Dr.
Palm Spring,  CA  92262
Correspondent Contact TOM GUTIERREZ
Regulation Number878.5070
Classification Product Code
FYD  
Date Received04/04/2000
Decision Date 06/15/2000
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
Recalls CDRH Recalls
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