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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 K811234
Device Name I.V. BOTTLE (RIDGID)
Applicant
Medi-Plast Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medi-Plast Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5025
Classification Product Code
KPE  
Date Received05/04/1981
Decision Date 06/18/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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