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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Spinal, Short Term
510(k) Number K961324
Device Name GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES
Applicant
Global Medical Prods, Inc.
No St. Address
Oakville Ont.L6l 5k9,  CA
Applicant Contact PETER CLARK
Correspondent
Global Medical Prods, Inc.
No St. Address
Oakville Ont.L6l 5k9,  CA
Correspondent Contact PETER CLARK
Regulation Number868.5150
Classification Product Code
MIA  
Date Received04/08/1996
Decision Date 07/02/1996
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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