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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Oral Irrigation
510(k) Number K952234
Device Name BARRIER ALL FILM
Applicant
Cottrell, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact FRANK S CASCIANI
Correspondent
Cottrell, Ltd.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact FRANK S CASCIANI
Regulation Number872.6510
Classification Product Code
EFS  
Date Received05/12/1995
Decision Date 07/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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