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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 K970997
Device Name NEO-CARE LUMBER PUNCTURE KIT
Applicant
KLEIN-BAKER MEDICAL, INC.
12001 NETWORK, SUITE 110
SAN ANTONIO,  TX  78249
Applicant Contact CLYDE N BAKER
Correspondent
KLEIN-BAKER MEDICAL, INC.
12001 NETWORK, SUITE 110
SAN ANTONIO,  TX  78249
Correspondent Contact CLYDE N BAKER
Regulation Number868.5150
Classification Product Code
MIA  
Date Received03/19/1997
Decision Date 05/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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