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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 K771791
Device Name NEEDLE COUNTING
Applicant
Chase Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Chase Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5570
Classification Product Code
MMK  
Date Received09/22/1977
Decision Date 10/04/1977
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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