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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K980210
Device Name VARIOUS SURGICAL OR PATIENT DRAPES
Applicant
Gel-Lite, LLC
4820 Executive Parkct., #110
Jacksonville,  FL  32216
Applicant Contact Ed Horton
Correspondent
Gel-Lite, LLC
4820 Executive Parkct., #110
Jacksonville,  FL  32216
Correspondent Contact Ed Horton
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/21/1998
Decision Date 05/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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