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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Blood, Non-Electromagnetic Radiation
510(k) Number K020060
Device Name ASTOFLO
Applicant
NATS CORP.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
NATS CORP.
30 NORTHPORT RD.
SOUND BEACH,  NY  11789 -1734
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number864.9205
Classification Product Code
BSB  
Date Received01/08/2002
Decision Date 03/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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