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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, spinal, short term
510(k) Number K983858
Device Name SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
Applicant
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
SIMS PORTEX, INC.
10 BOWMAN DR.
KEENE,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number868.5150
Classification Product Code
MIA  
Date Received11/02/1998
Decision Date 01/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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