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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, i.v.
510(k) Number K832247
Device Name I.V. BAG ADDISEAL
Applicant
BAXA CORP., SUB. OF COOK GROUP, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BAXA CORP., SUB. OF COOK GROUP, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5025
Classification Product Code
KPE  
Date Received07/11/1983
Decision Date 07/26/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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