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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laryngoscope, rigid
510(k) Number K944428
Device Name LITE-BLADE
Applicant
EARE CONSULTING SERVICE
P.O. BOX 1309
EILAT,  IL 88112
Applicant Contact EMANUEL A ROSEN
Correspondent
EARE CONSULTING SERVICE
P.O. BOX 1309
EILAT,  IL 88112
Correspondent Contact EMANUEL A ROSEN
Regulation Number868.5540
Classification Product Code
CCW  
Date Received09/12/1994
Decision Date 11/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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