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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K942200
Device Name ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS
Applicant
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD.
NORCROSS,  GA  30093
Applicant Contact THOMAS BONNER
Correspondent
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD.
NORCROSS,  GA  30093
Correspondent Contact THOMAS BONNER
Regulation Number878.4040
Classification Product Code
LYU  
Date Received05/05/1994
Decision Date 08/07/1995
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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