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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K921613
Device Name STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510
Applicant
Dept. of the Army
5109 Leesburg Pike
Falls Church,  VA  22041
Applicant Contact GREGORY P BEREZUK
Correspondent
Dept. of the Army
5109 Leesburg Pike
Falls Church,  VA  22041
Correspondent Contact GREGORY P BEREZUK
Regulation Number880.6880
Classification Product Code
FLE  
Date Received04/06/1992
Decision Date 01/29/1993
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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