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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 K920293
Device Name DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY
Applicant
Davis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury,  CT  06810
Applicant Contact KEVIN J CROSSEN
Correspondent
Davis & Geck, Inc.
American Cynamid Company
One Casper St.
Danbury,  CT  06810
Correspondent Contact KEVIN J CROSSEN
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/22/1992
Decision Date 04/21/1992
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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