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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K901095
Device Name BI-PHASE SET, ORAL, MAXILLOFACIAL SURGERY
Applicant
Grimm & Norton
64 Newtown Plz.
Plainview,  NY  11803
Applicant Contact RICHARD MORIARTY
Correspondent
Grimm & Norton
64 Newtown Plz.
Plainview,  NY  11803
Correspondent Contact RICHARD MORIARTY
Regulation Number872.4760
Classification Product Code
JEY  
Date Received03/07/1990
Decision Date 04/27/1990
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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