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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, ultrasonic, obstetric
510(k) Number K864151
Device Name 280SL IMAGING SYSTEM TRANVAGINAL PROBES
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD,  CT  06492
Applicant Contact JOSEPH P LENZEN
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
61 BARNES PARK RD., NORTH
WALLINGFORD,  CT  06492
Correspondent Contact JOSEPH P LENZEN
Regulation Number884.2960
Classification Product Code
HGL  
Date Received10/23/1986
Decision Date 03/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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