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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Ent
510(k) Number K894369
Device Name APDYNE PHENOL APPLICATOR KIT
Applicant
Apdyne Medical Co.
955 W. Idaho Ave.
Saint Paul,  MN  55117
Applicant Contact MICHAEL W WALSH
Correspondent
Apdyne Medical Co.
955 W. Idaho Ave.
Saint Paul,  MN  55117
Correspondent Contact MICHAEL W WALSH
Regulation Number874.5220
Classification Product Code
KCJ  
Date Received07/14/1989
Decision Date 10/12/1989
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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