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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 K863732
Device Name SURGICAL DRAPE & DRAPE ACCESSORIES
Applicant
Intera Corp.
P.O. Box 25376
Chattanooga,  TN  37422
Applicant Contact BRUCE LINDQUIST
Correspondent
Intera Corp.
P.O. Box 25376
Chattanooga,  TN  37422
Correspondent Contact BRUCE LINDQUIST
Regulation Number878.4370
Classification Product Code
KKX  
Date Received09/23/1986
Decision Date 10/23/1986
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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