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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bag, Ice
510(k) Number K810653
Device Name VINYL ICE BAG
Applicant
First Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
First Industries, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6050
Classification Product Code
KYR  
Date Received03/10/1981
Decision Date 03/27/1981
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
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