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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K864821
Device Name AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2
Applicant
Reichert-Jung, Inc.
122 Charlton St.
Southbridge,  MA  01550
Applicant Contact RICHARD F TAYLOR
Correspondent
Reichert-Jung, Inc.
122 Charlton St.
Southbridge,  MA  01550
Correspondent Contact RICHARD F TAYLOR
Regulation Number874.4760
Classification Product Code
EOB  
Date Received12/09/1986
Decision Date 02/10/1987
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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