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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Restorative And Impression Material
510(k) Number K941431
Device Name BONE GRAFT DELIVERY SYRINGES
Applicant
Bio-Interfaces, Inc.
11095 Flintkote Ave.
San Diego,  CA  92121
Applicant Contact JOHN F KAY
Correspondent
Bio-Interfaces, Inc.
11095 Flintkote Ave.
San Diego,  CA  92121
Correspondent Contact JOHN F KAY
Regulation Number872.4565
Classification Product Code
EID  
Date Received03/24/1994
Decision Date 07/12/1994
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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