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510(k) K911918

SWIVEL HORSESHOE HEADREST by Codman & Shurtleff, Inc. — Product Code HBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1991
Date Received
April 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headrest, Neurosurgical
Device Class
Class I
Regulation Number
882.4440
Review Panel
NE
Submission Type

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  • K172022 — CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (October 3, 2017)
  • K171862 — GALAXY G3 Mini Microcoil Delivery System (September 25, 2017)
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  • K171653 — YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (July 3, 2017)
  • K162563 — YOGA Microcatheter (January 5, 2017)
  • K162437 — Codman EDS3 CSF External Drainage System (October 28, 2016)

Other clearances for product code HBM

  • K911917 — CODMAN PEDIATRIC HORSESHOE HEADREST (July 17, 1991)
  • K822169 — SURGICAL HEAD SUPPORT (August 20, 1982)