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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K933569
Device Name PENT NOVA AUTOBLOCK SYRINGE
Applicant
Medi-Hut Co., Inc.
1333 New Hampshire Ave.,NW
Suite 400
Washington D.C.,  DC  20036
Applicant Contact DONALD E SEGAL
Correspondent
Medi-Hut Co., Inc.
1333 New Hampshire Ave.,NW
Suite 400
Washington D.C.,  DC  20036
Correspondent Contact DONALD E SEGAL
Regulation Number880.5860
Classification Product Code
MEG  
Date Received07/22/1993
Decision Date 06/09/1995
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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