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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 K962179
Device Name STAT IM 5000 CASSETTE AUTOCLAVE
Applicant
Scican
2002 Smallman St.
Pittsburgh,  PA  15222
Applicant Contact NEIL MCPHAIL
Correspondent
Scican
2002 Smallman St.
Pittsburgh,  PA  15222
Correspondent Contact NEIL MCPHAIL
Regulation Number880.6880
Classification Product Code
FLE  
Date Received06/06/1996
Decision Date 01/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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