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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Accessories
510(k) Number K993089
Device Name DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER
Applicant
Deroyal Cardiovascular, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Applicant Contact LOIS MARSH
Correspondent
Deroyal Cardiovascular, Inc.
200 Debusk Ln.
Knoxville,  TN  37849
Correspondent Contact LOIS MARSH
Regulation Number878.4580
Classification Product Code
FTA  
Date Received09/16/1999
Decision Date 10/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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