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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K884921
Device Name HEMO-SANITAS SYRINGE
Applicant
Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger
540 Madison Ave.
New York,  NY  10022
Applicant Contact GLAZIER, PC
Correspondent
Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger
540 Madison Ave.
New York,  NY  10022
Correspondent Contact GLAZIER, PC
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/28/1988
Decision Date 02/09/1989
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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