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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Laser, Neodymium:Yag, Pulmonary Surgery
510(k) Number K861921
Device Name LASER BRONCHOSCOPE SYSTEM
Applicant
PILLING CO.
420 DELAWARE DR.
FORT WASHINGTON,  PA  19034
Applicant Contact LELAND J WIMER
Correspondent
PILLING CO.
420 DELAWARE DR.
FORT WASHINGTON,  PA  19034
Correspondent Contact LELAND J WIMER
Regulation Number874.4500
Classification Product Code
LLO  
Date Received05/19/1986
Decision Date 06/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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