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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pad, eye
510(k) Number K921349
Device Name STERILE,DISPOSABLE EYE DRESSING
Applicant
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Applicant Contact DEBRA MANNING
Correspondent
DEROYAL INDUSTRIES, INC.
200 DEBUSK LN.
POWELL,  TN  37849
Correspondent Contact DEBRA MANNING
Regulation Number878.4440
Classification Product Code
HMP  
Date Received03/19/1992
Decision Date 05/29/1992
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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