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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Surgical
510(k) Number K882613
Device Name ALM SURGICAL LAMPS
Applicant
Alm Surgical Equipment, Inc.
30 N. Raymond Ave. Suite
305
Pasadena,  CA  91103
Applicant Contact A, YOUNG
Correspondent
Alm Surgical Equipment, Inc.
30 N. Raymond Ave. Suite
305
Pasadena,  CA  91103
Correspondent Contact A, YOUNG
Regulation Number878.4580
Classification Product Code
FTD  
Date Received06/24/1988
Decision Date 07/18/1988
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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