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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K003194
Device Name STACKHOUSE LENS HOOD, MODEL SA-700/FS
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 Number878.4040
Classification Product Code
FYA  
Date Received10/12/2000
Decision Date 10/26/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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