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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 K883424
Device Name SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB
Applicant
Intera Corp.
P.O. Box 25376
Chattanooga,  TN  37422
Applicant Contact LARRY ENGLISH
Correspondent
Intera Corp.
P.O. Box 25376
Chattanooga,  TN  37422
Correspondent Contact LARRY ENGLISH
Regulation Number878.4370
Classification Product Code
KKX  
Date Received08/15/1988
Decision Date 09/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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