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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 K011209
Device Name MANAN SPRITACRE SPINAL NEEDLES
Applicant
MANAN MEDICAL PRODUCTS, INC.
241 W. PALATINE RD.
WHEELING,  IL  60090
Applicant Contact ROBBIE PALADUGU
Correspondent
MANAN MEDICAL PRODUCTS, INC.
241 W. PALATINE RD.
WHEELING,  IL  60090
Correspondent Contact ROBBIE PALADUGU
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/19/2001
Decision Date 06/26/2001
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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