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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K911039
Device Name INVOTEC EAR DRAPE
Applicant
Invotec International, Inc.
11330-1st. John'S Industrial
Pkwy.
Jacksonville,  FL  32216
Applicant Contact JEFFREY L AULL
Correspondent
Invotec International, Inc.
11330-1st. John'S Industrial
Pkwy.
Jacksonville,  FL  32216
Correspondent Contact JEFFREY L AULL
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/08/1991
Decision Date 05/13/1991
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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