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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, empty, for collection & processing of blood & blood components
510(k) Number K811449
Device Name HAEMONETICS 1000ML COMPONENT BAG
Applicant
HAEMONETICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HAEMONETICS CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number864.9100
Classification Product Code
KSR  
Date Received05/22/1981
Decision Date 07/01/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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