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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 K000144
Device Name NIPRO INSULIN SYRINGE
Applicant
NIPRO MEDICAL CORP.
3150 NW 107 AVE..
MIAMI,  FL  33172
Applicant Contact GARY GOLDSMITH
Correspondent
NIPRO MEDICAL CORP.
3150 NW 107 AVE..
MIAMI,  FL  33172
Correspondent Contact GARY GOLDSMITH
Regulation Number880.5860
Classification Product Code
FMF  
Date Received01/18/2000
Decision Date 02/11/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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