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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K983620
Device Name MANAN SPINAL NEEDLES
Applicant
MANAN MEDICAL PRODUCTS, INC.
2200 CARLSON DR.
NORTHBROOK,  IL  60062
Applicant Contact MICHAEL PLISHKA
Correspondent
MANAN MEDICAL PRODUCTS, INC.
2200 CARLSON DR.
NORTHBROOK,  IL  60062
Correspondent Contact MICHAEL PLISHKA
Regulation Number868.5150
Classification Product Code
BSP  
Date Received10/15/1998
Decision Date 01/08/1999
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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