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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 NORTH LEMON ST.
ANAHEIM,  CA  92801 -1009
Applicant Contact SUSAN NIELSEN
Correspondent
ALM SURGICAL EQUIPMENT, INC.
1820 NORTH LEMON ST.
ANAHEIM,  CA  92801 -1009
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
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