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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Subperiosteal
510(k) Number K843557
Device Name K-APATITE 20-40 MESH K-APATITE 40-60
Applicant
Katecho, Inc.
2302 SW 9th. St.
Des Moines,  IA  50315 -
Applicant Contact LORNE SCHARNBERG
Correspondent
Katecho, Inc.
2302 SW 9th. St.
Des Moines,  IA  50315 -
Correspondent Contact LORNE SCHARNBERG
Regulation Number872.3645
Classification Product Code
ELE  
Date Received09/10/1984
Decision Date 11/30/1984
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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