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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, pneumoperitoneum, simple
510(k) Number K860102
Device Name MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE
Applicant
ENDOTHERAPEUTICS
654 BAIR ISLAND RD.
SUITE 209
REDWOOD CITY,  CA  94063
Applicant Contact RUSSELL THOMPSON
Correspondent
ENDOTHERAPEUTICS
654 BAIR ISLAND RD.
SUITE 209
REDWOOD CITY,  CA  94063
Correspondent Contact RUSSELL THOMPSON
Regulation Number876.1500
Classification Product Code
FHP  
Date Received01/10/1986
Decision Date 02/12/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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