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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
Predetermined Change
Control Plan Authorized		 No
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