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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 K991160
Device Name ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
Applicant
Stihler Electronic GmbH
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact RICHARD C LANZILLOTTO
Correspondent
Stihler Electronic GmbH
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact RICHARD C LANZILLOTTO
Regulation Number864.9205
Classification Product Code
BSB  
Date Received04/07/1999
Decision Date 09/02/1999
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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