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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Nasal
510(k) Number K962698
Device Name ACUTEK'S CLEARPASAGE
Applicant
Acutek Adhesive Specialties, Inc.
540 N. Oak St.
Inglewood,  CA  90302
Applicant Contact MARCIA FAJARDO
Correspondent
Acutek Adhesive Specialties, Inc.
540 N. Oak St.
Inglewood,  CA  90302
Correspondent Contact MARCIA FAJARDO
Regulation Number874.3900
Classification Product Code
LWF  
Date Received06/17/1996
Decision Date 09/09/1996
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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