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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 K922307
Device Name SHOWERFLOSS ORAL IRRIGATION UNIT
Applicant
Showerfloss, Inc.
26300 Hickory Blvd. #1105
Bonita Springs,  FL  33923
Applicant Contact CLYDE F STEWART
Correspondent
Showerfloss, Inc.
26300 Hickory Blvd. #1105
Bonita Springs,  FL  33923
Correspondent Contact CLYDE F STEWART
Regulation Number872.6510
Classification Product Code
EFS  
Date Received05/15/1992
Decision Date 06/16/1992
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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