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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Fluid Delivery
510(k) Number K874360
Device Name PLASTIC TUBING CONNECTOR
Applicant
AMERICAN MEDICAL TECHNOLOGY, INC.
C/O VENTURE MGMT CONSULTING
BOX 160 GRAND VIEW TERRACE EXT
BROOKLYN,  CT  06234
Applicant Contact GENE ZAMBA
Correspondent
AMERICAN MEDICAL TECHNOLOGY, INC.
C/O VENTURE MGMT CONSULTING
BOX 160 GRAND VIEW TERRACE EXT
BROOKLYN,  CT  06234
Correspondent Contact GENE ZAMBA
Regulation Number880.5440
Classification Product Code
FPK  
Date Received10/23/1987
Decision Date 11/17/1987
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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