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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 K801309
Device Name RITTER STERILIZER
Applicant
Sybron Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sybron Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6880
Classification Product Code
FLE  
Date Received06/03/1980
Decision Date 06/20/1980
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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