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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 K963570
Device Name SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
Applicant
Smiths Industries Medical Systems, Inc.
15 Kit St.
Keene,  NH  03431
Applicant Contact TIMOTHY J TALCOTT
Correspondent
Smiths Industries Medical Systems, Inc.
15 Kit St.
Keene,  NH  03431
Correspondent Contact TIMOTHY J TALCOTT
Regulation Number880.2500
Classification Product Code
FMJ  
Date Received09/05/1996
Decision Date 10/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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