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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 K961886
Device Name DRAGER GEMINA WALL-MOUNTED WORKPLACE
Applicant
Alm Surgical Equipment, Inc.
1820 N. Lemon St.
Anaheim,  CA  92801 -1009
Applicant Contact SUSAN NIELSON
Correspondent
Alm Surgical Equipment, Inc.
1820 N. Lemon St.
Anaheim,  CA  92801 -1009
Correspondent Contact SUSAN NIELSON
Regulation Number878.4960
Classification Product Code
FQO  
Subsequent Product Code
BRY  
Date Received05/15/1996
Decision Date 07/30/1996
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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