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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Clip, Scalp
510(k) Number K881265
Device Name RANEY CLIPS
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Applicant Contact MAX SHERMAN
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Correspondent Contact MAX SHERMAN
Regulation Number882.4150
Classification Product Code
HBO  
Date Received03/24/1988
Decision Date 05/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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