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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 K971000
Device Name EPISTAXIS NASAL PACK
Applicant
Invotec International, Inc.
11243-1 St. Johns Industrial
Pkwy. S.
Jacksonville,  FL  32246
Applicant Contact JEFFREY L AULL
Correspondent
Invotec International, Inc.
11243-1 St. Johns Industrial
Pkwy. S.
Jacksonville,  FL  32246
Correspondent Contact JEFFREY L AULL
Regulation Number874.4100
Classification Product Code
EMX  
Date Received03/19/1997
Decision Date 05/14/1997
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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