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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostat
510(k) Number K920298
Device Name DISPOSABLE HEMOSTATS
Applicant
Falcon Instruments, Inc.
8309 Bryant Dr.
Bethesda,  MD  20817
Applicant Contact NEAL DUNNING
Correspondent
Falcon Instruments, Inc.
8309 Bryant Dr.
Bethesda,  MD  20817
Correspondent Contact NEAL DUNNING
Regulation Number878.4800
Classification Product Code
HRQ  
Date Received01/22/1992
Decision Date 08/11/1992
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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