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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Pressure, Intrauterine
510(k) Number K883832
Device Name CATHETER, INTRAUTERINE AND INTRODUCER
Applicant
TELOS MEDICAL CORP.
2044 WEST 11TH ST.
KEENE,  CA  91786
Applicant Contact TIMOTHY J TALCOTT
Correspondent
TELOS MEDICAL CORP.
2044 WEST 11TH ST.
KEENE,  CA  91786
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number884.2700
Classification Product Code
KXO  
Date Received09/09/1988
Decision Date 12/13/1988
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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