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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 K884790
Device Name QUALTEX NEUROLOK SURGICAL SPONGE
Applicant
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Applicant Contact WYATT ZACHRY
Correspondent
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Correspondent Contact WYATT ZACHRY
Regulation Number878.4450
Classification Product Code
GDY  
Date Received11/15/1988
Decision Date 12/09/1988
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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