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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., S.
P.O. Box 505
Woodbury,  CT  06798
Applicant Contact PETER CLARK
Correspondent
Global Medical Products, Ltd.
244 Main St., S.
P.O. Box 505
Woodbury,  CT  06798
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
Predetermined Change
Control Plan Authorized		 No
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