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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Sinus
510(k) Number K922902
Device Name SALMAN SINUS BUTTON
Applicant
Boston Medical Products, Inc.
87 Rumford Ave.
Waltham,  MA  02154
Applicant Contact STUART K MONTGOMERY
Correspondent
Boston Medical Products, Inc.
87 Rumford Ave.
Waltham,  MA  02154
Correspondent Contact STUART K MONTGOMERY
Regulation Number878.4800
Classification Product Code
KAM  
Date Received06/16/1992
Decision Date 05/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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