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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon, Epistaxis
510(k) Number K933800
Device Name FLUOROFILM(R)
Applicant
American Custom Medical, Inc.
3403 73rd St.
Lubbock,  TX  79413
Applicant Contact BRUCE G RUEFER
Correspondent
American Custom Medical, Inc.
3403 73rd St.
Lubbock,  TX  79413
Correspondent Contact BRUCE G RUEFER
Regulation Number874.4100
Classification Product Code
EMX  
Date Received08/04/1993
Decision Date 06/24/1994
Decision Substantially Equivalent (SESE)
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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