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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ent microsurgical carbon-dioxide
510(k) Number K862150
Device Name MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
Applicant
DIRECTED ENERGY, INC.
11661 SAN VICENTE BLVD.
SUITE 203
LOS ANGELES,  CA  90049
Applicant Contact EDWARD JOHANSEN
Correspondent
DIRECTED ENERGY, INC.
11661 SAN VICENTE BLVD.
SUITE 203
LOS ANGELES,  CA  90049
Correspondent Contact EDWARD JOHANSEN
Regulation Number874.4500
Classification Product Code
EWG  
Date Received06/04/1986
Decision Date 09/04/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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