MODEL 545-45 LASER FOR EAR, NOSE & THROAT

Laser, Ent Microsurgical Carbon-dioxide

BRITT CORP., INC.

The following data is part of a premarket notification filed by Britt Corp., Inc. with the FDA for Model 545-45 Laser For Ear, Nose & Throat.

Pre-market Notification Details

Device IDK860975
510k NumberK860975
Device Name:MODEL 545-45 LASER FOR EAR, NOSE & THROAT
ClassificationLaser, Ent Microsurgical Carbon-dioxide
Applicant BRITT CORP., INC. 2231 SOUTH BARRINGTON AVE. Los Angeles,  CA  90064
ContactJeffrey Green
CorrespondentJeffrey Green
BRITT CORP., INC. 2231 SOUTH BARRINGTON AVE. Los Angeles,  CA  90064
Product CodeEWG  
CFR Regulation Number874.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-03-14
Decision Date1986-07-18

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