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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Ceiling Mounted
510(k) Number K982063
Device Name ALM PRISMALIX (PRX) SURGICAL LIGHT
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 Number878.4580
Classification Product Code
FSY  
Date Received06/12/1998
Decision Date 09/22/1998
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
Recalls CDRH Recalls
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