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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 K921848
Device Name BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
Applicant
ALM SURGICAL EQUIPMENT, INC.
3323 WEST WARNER AVE.
SANTA ANA,  CA  92704
Applicant Contact SUSAN NIELSEN
Correspondent
ALM SURGICAL EQUIPMENT, INC.
3323 WEST WARNER AVE.
SANTA ANA,  CA  92704
Correspondent Contact SUSAN NIELSEN
Regulation Number878.4580
Classification Product Code
FSQ  
Date Received04/17/1992
Decision Date 10/01/1992
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
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