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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 K923457
Device Name SHOWERFLOSS
Applicant
Summit Marketing Group, Inc.
32911 4th Ave. SW
Federal Way,  WA  98023
Applicant Contact RANDALL GUSTAFSON
Correspondent
Summit Marketing Group, Inc.
32911 4th Ave. SW
Federal Way,  WA  98023
Correspondent Contact RANDALL GUSTAFSON
Regulation Number872.6510
Classification Product Code
EFS  
Date Received07/14/1992
Decision Date 09/01/1992
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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