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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Rubeola
510(k) Number K922870
Device Name THREE SPIKE CUP
Applicant
Osteo Technology, Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Osteo Technology, Inc.
10 W. Aylesbury Rd.
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number866.3520
Classification Product Code
GRF  
Date Received06/04/1992
Decision Date 04/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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