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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K801331
Device Name AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS
Applicant
Associated Medical Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Associated Medical Products Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6850
Classification Product Code
FRG  
Date Received06/03/1980
Decision Date 08/20/1980
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
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