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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Ear
510(k) Number K834168
Device Name FIBRINOGEN UPTAKE SYS -VARIOUS MODELS
Applicant
Canberra Industries, Inc.
45 Gracey Ave.
Meriden,  CT  06450
Applicant Contact RON SIMMONS
Correspondent
Canberra Industries, Inc.
45 Gracey Ave.
Meriden,  CT  06450
Correspondent Contact RON SIMMONS
Regulation Number874.4420
Classification Product Code
JZD  
Date Received11/04/1983
Decision Date 12/29/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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