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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827448
Device Name BSINUS DIAPHANOGRAPH
Applicant
Sinus Medical, Inc.
1915 NE 45th St.
Ft Lauderdale,  FL  33308
Correspondent
Sinus Medical, Inc.
1915 NE 45th St.
Ft Lauderdale,  FL  33308
Date Received04/22/1982
Decision Date 05/19/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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