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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Removable (Skin)
510(k) Number K911204
Device Name QUALTEX SKIN STAPLE EXTRACTOR
Applicant
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Applicant Contact DEBUSK LANE
Correspondent
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Correspondent Contact DEBUSK LANE
Regulation Number878.4760
Classification Product Code
GDT  
Date Received03/19/1991
Decision Date 05/08/1991
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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