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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 K960405
Device Name SPINAL NEEDLE
Applicant
PROMEX, INC.
1125 BROOKSIDE AVE.
SUITE G500
INDIANAPOLIS,  IN  46202
Applicant Contact JOSEPH L MARK
Correspondent
PROMEX, INC.
1125 BROOKSIDE AVE.
SUITE G500
INDIANAPOLIS,  IN  46202
Correspondent Contact JOSEPH L MARK
Regulation Number868.5150
Classification Product Code
MIA  
Date Received01/29/1996
Decision Date 02/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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