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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Ent Drug
510(k) Number K942789
Device Name MISTASSIST
Applicant
THE MERLIN CORP.
1127 GARRIDO DR.
CAMARILLO,  CA  93010
Applicant Contact PAUL DWORK PHARMB
Correspondent
THE MERLIN CORP.
1127 GARRIDO DR.
CAMARILLO,  CA  93010
Correspondent Contact PAUL DWORK PHARMB
Regulation Number874.5220
Classification Product Code
LRD  
Date Received06/14/1994
Decision Date 08/12/1994
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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