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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dam, Rubber
510(k) Number K923163
Device Name RUBBER DAM CLAMP
Applicant
Aseptico, Inc.
P.O. Box 3209
Kirkland,  WA  98083
Applicant Contact DOUGLASS H KAZEN
Correspondent
Aseptico, Inc.
P.O. Box 3209
Kirkland,  WA  98083
Correspondent Contact DOUGLASS H KAZEN
Regulation Number872.6300
Classification Product Code
EIE  
Date Received06/29/1992
Decision Date 12/28/1992
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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