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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K853828
Device Name FLS MED. PROD. RACINE TYPE ADAPTOR
Applicant
FLS MEDICAL PRODUCTS, INC.
5081 69TH. AVENUE NORTH
PINELLAS PARK,  FL  33565
Applicant Contact FRANCIS L SANDEL
Correspondent
FLS MEDICAL PRODUCTS, INC.
5081 69TH. AVENUE NORTH
PINELLAS PARK,  FL  33565
Correspondent Contact FRANCIS L SANDEL
Regulation Number868.5810
Classification Product Code
BZA  
Date Received09/13/1985
Decision Date 10/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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