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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K921297
Device Name DRAGER DVE 4000 SERIES SYSTEM
Applicant
Alm Surgical Equipment, Inc.
3323 W. Warner Ave.
Santa Ana,  CA  92704
Applicant Contact KAREN YOUNG
Correspondent
Alm Surgical Equipment, Inc.
3323 W. Warner Ave.
Santa Ana,  CA  92704
Correspondent Contact KAREN YOUNG
Regulation Number878.4960
Classification Product Code
FQO  
Date Received03/17/1992
Decision Date 11/27/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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