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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 K911206
Device Name MAXIMA-10
Applicant
Stirn Industries
1095 Cranbury So. River Rd.
P.O. Box 407
Dayton,  NJ  08810
Applicant Contact ROBERT HARRINGTON
Correspondent
Stirn Industries
1095 Cranbury So. River Rd.
P.O. Box 407
Dayton,  NJ  08810
Correspondent Contact ROBERT HARRINGTON
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/19/1991
Decision Date 11/29/1991
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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