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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Sinus
510(k) Number K912418
Device Name SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE
Applicant
Micromedics, Inc.
268 E. Lafayette Frontage
Rd.
St. Paul,  MN  55107
Applicant Contact CURTIS H MILLER
Correspondent
Micromedics, Inc.
268 E. Lafayette Frontage
Rd.
St. Paul,  MN  55107
Correspondent Contact CURTIS H MILLER
Regulation Number878.4800
Classification Product Code
KAM  
Date Received05/31/1991
Decision Date 12/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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