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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K942905
Device Name DISPOSABLE TEMPERATURE PROBE COVER
Applicant
Arbo Medical, Inc.
300 Long Beach Blvd.
Stratford,  CT  06497
Applicant Contact MARK M PETRAHAI
Correspondent
Arbo Medical, Inc.
300 Long Beach Blvd.
Stratford,  CT  06497
Correspondent Contact MARK M PETRAHAI
Regulation Number880.5130
Classification Product Code
FMT  
Date Received06/21/1994
Decision Date 02/27/1995
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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