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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 K890443
Device Name CASPAR SCALP CLIP, APPLIER
Applicant
Aesculap Instruments Corp.
875 Stanton Rd.
Burlingame,  CA  94010
Applicant Contact ROBIN BUSH
Correspondent
Aesculap Instruments Corp.
875 Stanton Rd.
Burlingame,  CA  94010
Correspondent Contact ROBIN BUSH
Regulation Number882.4150
Classification Product Code
HBO  
Date Received01/27/1989
Decision Date 06/15/1989
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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