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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name retractor, self-retaining, for neurosurgery
510(k) Number K892543
Device Name NEUROSURICAL RETRACTORS - VARIOUS TYPES
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
21540-B PRAIRIE ST.
CHATSWORTH,  CA  91311
Applicant Contact ANNA STRAIGHT
Correspondent
ZINNANTI SURGICAL INSTRUMENTS, INC.
21540-B PRAIRIE ST.
CHATSWORTH,  CA  91311
Correspondent Contact ANNA STRAIGHT
Regulation Number882.4800
Classification Product Code
GZT  
Date Received04/11/1989
Decision Date 05/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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