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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K931093
Device Name QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE
Applicant
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Applicant Contact BILL RANSING
Correspondent
Dentalez Group
1816 Colonial Village Ln.
Lancaster,  PA  17601
Correspondent Contact BILL RANSING
Regulation Number872.6640
Classification Product Code
EIA  
Date Received03/03/1993
Decision Date 01/21/1994
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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