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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Surgical
510(k) Number K982059
Device Name ROTECNO 2000 SURGICAL GOWN
Applicant
Encompass Group, LLC
615 Macon Rd.
Mcdonough,  GA  30253
Applicant Contact TIM CUMMINS
Correspondent
Encompass Group, LLC
615 Macon Rd.
Mcdonough,  GA  30253
Correspondent Contact TIM CUMMINS
Regulation Number878.4040
Classification Product Code
FYA  
Date Received06/11/1998
Decision Date 11/30/1998
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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