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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Dental
510(k) Number K990511
Device Name X-TIP INTRAOSSEOUS PERFORATOR
Applicant
Schiff & Co.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Schiff & Co.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number872.4730
Classification Product Code
DZM  
Date Received02/18/1999
Decision Date 04/27/1999
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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