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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 K982269
Device Name CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA
Applicant
Allegiance Healthcare Corp.
1500 Waukegan Rd.- K
Mcgraw Park,  IL  60085
Applicant Contact ZARINA B ILGRAMI
Correspondent
Allegiance Healthcare Corp.
1500 Waukegan Rd.- K
Mcgraw Park,  IL  60085
Correspondent Contact ZARINA B ILGRAMI
Regulation Number868.5150
Classification Product Code
MIA  
Date Received06/29/1998
Decision Date 07/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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