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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amalgamator, Dental, Ac-Powered
510(k) Number K922203
Device Name IPT CAPSULE MIXER
Applicant
Ipt Technologies, Inc.
2550 N. Federal Hwy.
Fort Lauderdale,  FL  33305
Applicant Contact INGOLF V JANERUS
Correspondent
Ipt Technologies, Inc.
2550 N. Federal Hwy.
Fort Lauderdale,  FL  33305
Correspondent Contact INGOLF V JANERUS
Regulation Number872.3100
Classification Product Code
EFD  
Date Received05/11/1992
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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