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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 K921999
Device Name INTERJET(TM) GINGIVAL CARE INSTRUMENT
Applicant
Bausch & Lomb, Inc.
5243 Royal Woods Pkwy., #100
Tucker,  GA  30084
Applicant Contact STEPHENS
Correspondent
Bausch & Lomb, Inc.
5243 Royal Woods Pkwy., #100
Tucker,  GA  30084
Correspondent Contact STEPHENS
Regulation Number872.6510
Classification Product Code
EFS  
Date Received04/29/1992
Decision Date 06/03/1992
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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