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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, Instrument
510(k) Number K922409
Device Name ALM ILLUMINATOR SERIES LIGHT SYSTEM
Applicant
ALM SURGICAL EQUIPMENT, INC.
3323 WEST WARNER AVE.
SANTA ANA,  CA  92704
Applicant Contact SUSAN NIELSON
Correspondent
ALM SURGICAL EQUIPMENT, INC.
3323 WEST WARNER AVE.
SANTA ANA,  CA  92704
Correspondent Contact SUSAN NIELSON
Regulation Number878.4580
Classification Product Code
FSQ  
Date Received05/21/1992
Decision Date 01/12/1993
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
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