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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 K950897
Device Name BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE)
Applicant
Biosystems
210 Sherwood Ave.
Farmingdale,  NY  11735
Applicant Contact JANE E RUBINSTEIN
Correspondent
Biosystems
210 Sherwood Ave.
Farmingdale,  NY  11735
Correspondent Contact JANE E RUBINSTEIN
Regulation Number880.5570
Classification Product Code
MMK  
Subsequent Product Code
FMI  
Date Received02/27/1995
Decision Date 08/24/1995
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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