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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gauze/sponge, internal, x-ray detectable
510(k) Number K940764
Device Name OREX
Applicant
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD, NW
NORCROSS,  GA  30093
Applicant Contact TRAVIS HONEYCUTT
Correspondent
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD, NW
NORCROSS,  GA  30093
Correspondent Contact TRAVIS HONEYCUTT
Regulation Number878.4450
Classification Product Code
GDY  
Date Received02/18/1994
Decision Date 12/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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