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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, larynx (stents and keels)
510(k) Number K864936
Device Name 'EXMOOR' DAS GUPTA LARYNGEAL KEEL
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Applicant Contact BRIAN EAST
Correspondent
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET,  GB TA1 2LB
Correspondent Contact BRIAN EAST
Regulation Number874.3620
Classification Product Code
FWN  
Date Received12/16/1986
Decision Date 04/27/1987
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
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