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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K833483
Device Name ENDOSCOPIC COUPLER
Applicant
MERRIMACK LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MERRIMACK LABORATORIES
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/07/1983
Decision Date 02/10/1984
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
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