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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manometer, Spinal-Fluid
510(k) Number K882405
Device Name HYPODERMIC NEEDLE SHEATH HOLDER
Applicant
Ansr Ent., Inc.
1775 S. Tomichi
Franktown,  CO  80116
Applicant Contact WAYNE R TURNER
Correspondent
Ansr Ent., Inc.
1775 S. Tomichi
Franktown,  CO  80116
Correspondent Contact WAYNE R TURNER
Regulation Number880.2500
Classification Product Code
FMJ  
Date Received06/10/1988
Decision Date 06/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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