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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 K872313
Device Name NEEDLE & BLADE COUNTER & DISPOSAL UNIT
Applicant
Gary Plastic Packaging Corp.
770 Garrison Ave.
Bronx,  NY  10474
Applicant Contact LISA HELLINGER
Correspondent
Gary Plastic Packaging Corp.
770 Garrison Ave.
Bronx,  NY  10474
Correspondent Contact LISA HELLINGER
Regulation Number880.5570
Classification Product Code
MMK  
Date Received06/17/1987
Decision Date 07/02/1987
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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