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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 K875153
Device Name THIELER KIT
Applicant
Taris Corp.
2386 Shannon Rd.
Fernandina Beach,  FL  32034
Applicant Contact WILLIAM J SCHRODER
Correspondent
Taris Corp.
2386 Shannon Rd.
Fernandina Beach,  FL  32034
Correspondent Contact WILLIAM J SCHRODER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/15/1987
Decision Date 02/18/1988
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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