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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K810134
Device Name KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM
Applicant
Info-Chem
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Info-Chem
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.5570
Classification Product Code
MMK  
Date Received01/19/1981
Decision Date 02/26/1981
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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