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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Hemostat, Surgical
510(k) Number K920883
Device Name HEMOSTAT, SURGICAL (VARIOUS TYPES)
Applicant
S.T.S Instruments
766 E. 9th St.
Brooklyn,  NY  11230
Applicant Contact RIAZ SALEEM
Correspondent
S.T.S Instruments
766 E. 9th St.
Brooklyn,  NY  11230
Correspondent Contact RIAZ SALEEM
Regulation Number872.4565
Classification Product Code
EMD  
Date Received02/26/1992
Decision Date 03/13/1992
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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