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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 K983227
Device Name POWER BLOCK
Applicant
Kreativ, Inc.
9025 Balboa Ave.
San Diego,  CA  92123
Applicant Contact JOSEPH M FOREHAND
Correspondent
Kreativ, Inc.
9025 Balboa Ave.
San Diego,  CA  92123
Correspondent Contact JOSEPH M FOREHAND
Regulation Number872.6300
Classification Product Code
EIE  
Date Received09/15/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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