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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 K961444
Device Name GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725)
Applicant
GLOBAL MEDICAL PRODUCTS, LTD.
244 MAIN ST., SOUTH
P.O. BOX 505
WOODBURY,  CT  06798 -0505
Applicant Contact PETER CLARK
Correspondent
GLOBAL MEDICAL PRODUCTS, LTD.
244 MAIN ST., SOUTH
P.O. BOX 505
WOODBURY,  CT  06798 -0505
Correspondent Contact PETER CLARK
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/15/1996
Decision Date 08/01/1996
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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