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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 K952275
Device Name GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
Applicant
GLOBAL MEDICAL PRODS, INC.
2230 NURSERY RD.
UNIT D41
CLEARWATER,  FL  34624
Applicant Contact DONALD F RYAN
Correspondent
GLOBAL MEDICAL PRODS, INC.
2230 NURSERY RD.
UNIT D41
CLEARWATER,  FL  34624
Correspondent Contact DONALD F RYAN
Regulation Number868.5150
Classification Product Code
BSP  
Date Received05/15/1995
Decision Date 10/11/1995
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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