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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti Fog Solution And Accessories, Endoscopy
510(k) Number K982465
Device Name DEROYAL INDUSTRIES, INC. DEFOGGER
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact LOIS MARSH
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact LOIS MARSH
Regulation Number876.1500
Classification Product Code
OCT  
Date Received07/15/1998
Decision Date 08/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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