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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Supplies, Blood-Bank
510(k) Number K874436
Device Name FLUID SAMPLING PACK
Applicant
U.S. Mfg. & Management, Inc.
287 S. Stoddard Ave.
San Bernardino,  CA  92401
Applicant Contact FRANK J RAUSCHER
Correspondent
U.S. Mfg. & Management, Inc.
287 S. Stoddard Ave.
San Bernardino,  CA  92401
Correspondent Contact FRANK J RAUSCHER
Regulation Number864.9050
Classification Product Code
KSS  
Date Received10/28/1987
Decision Date 01/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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