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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 K961742
Device Name DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
Applicant
Alm Surgical Equipment, Inc.
1820 N. Lemon St.
Anaheim,  CA  92801
Applicant Contact SUSAN NIELSEN
Correspondent
Alm Surgical Equipment, Inc.
1820 N. Lemon St.
Anaheim,  CA  92801
Correspondent Contact SUSAN NIELSEN
Regulation Number878.4960
Classification Product Code
FQO  
Date Received05/06/1996
Decision Date 07/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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