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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 K890359
Device Name RESUBMITTED STC SERIES 8600 AUTOCLAVE
Applicant
Sterilizer Technologies Corp.
3200 Northline Ave., Suite 636-
J
Greensboro,  NC  27408
Applicant Contact REUBEN MARGOLIASH
Correspondent
Sterilizer Technologies Corp.
3200 Northline Ave., Suite 636-
J
Greensboro,  NC  27408
Correspondent Contact REUBEN MARGOLIASH
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/25/1989
Decision Date 08/07/1989
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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