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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 K971645
Device Name REGANES SPINAL NEEDLE (VARIOUS)
Applicant
AVID N.I.T., INC.
917 KLOSTERMAN RD. EAST
TARPON SPRINGS,  FL  34689
Applicant Contact JOSEPH E HARMS
Correspondent
AVID N.I.T., INC.
917 KLOSTERMAN RD. EAST
TARPON SPRINGS,  FL  34689
Correspondent Contact JOSEPH E HARMS
Regulation Number868.5150
Classification Product Code
MIA  
Date Received05/05/1997
Decision Date 08/01/1997
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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