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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Biopsy, Bronchoscope (Non-Rigid)
510(k) Number K182927
Device Name Pulmonary Cytology Brush
Applicant
Hobbs Medical, Inc.
8 Spring St.
Stafford Springs,  CT  06076
Applicant Contact Carlos O. Acosta
Correspondent
Hobbs Medical, Inc.
8 Spring St.
Stafford Springs,  CT  06076
Correspondent Contact Carlos O. Acosta
Regulation Number874.4680
Classification Product Code
BTG  
Date Received10/22/2018
Decision Date 02/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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