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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 K912885
Device Name KAPS 90 DEGREE FIBEROPTIC ADAPTOR
Applicant
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129 -2217
Applicant Contact CRAIG RAPP
Correspondent
Jedmed Instrument Co.
6096 Lemay Ferry Rd.
St.Louis,  MO  63129 -2217
Correspondent Contact CRAIG RAPP
Regulation Number874.4350
Classification Product Code
EQH  
Date Received07/01/1991
Decision Date 08/30/1991
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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