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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K923774
Device Name DISPOSABLE ENDOILLUMINATOR
Applicant
O.R. Specialties, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405
Applicant Contact JACK W HOWARD
Correspondent
O.R. Specialties, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405
Correspondent Contact JACK W HOWARD
Regulation Number874.4350
Classification Product Code
EQH  
Date Received07/28/1992
Decision Date 10/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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