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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name flowmeter, calibration, gas
510(k) Number K851460
Device Name NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA
Applicant
TELECTRONICS, INC.
40 CRANE HILL RD.
SUFFIELD,  CT  06078
Applicant Contact WILLIAM C NEALON
Correspondent
TELECTRONICS, INC.
40 CRANE HILL RD.
SUFFIELD,  CT  06078
Correspondent Contact WILLIAM C NEALON
Regulation Number868.2350
Classification Product Code
BXY  
Date Received04/11/1985
Decision Date 05/10/1985
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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