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510(k) K041215

Device
CRANIAL HELMET
Applicant
OTTO BOCK HEALTH CARE, LP
510(k) number
K041215
Product code
MVA  
Decision
Substantially Equivalent (SESE)
Decision date
2004-09-09
Date received
2004-05-10
Regulation
882.5970
Classification name
Orthosis, Cranial
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SHELLEY STOCKMAN
Address
2 Carlson Pwy. Suite 100 Minneapolis MN US 55447 55447

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MVA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241957Talee, Talee PostOpInvent Medical USA, LLC2024-08-30
K230444Talee, Talee PostOpInvent Medical USA, LLC2023-06-22
K223238STARband 3DOrthomerica Products, Inc.2023-04-20
K220681Talee, Talee PostOPInvent Medical USA, LLC2022-09-22
K203134Hanger Cranial Band 3DSymbion Logistics, LLC2022-07-01
K213587MyCRO BandOtto Bock Healthcare LP2022-06-09
K193383SnugKapHeadstart, Ltd.2021-06-07
K201426MyCRO BandOtto Bock Healthcare LP2021-03-26
K180568KidCapEastern Cranial Affiliates, LLC2018-10-16
K141842STARBAND, STARLIGHTOrthomerica Products, Inc.2014-10-06
K140353STARBAND AND STARLIGHTOrthomerica Products, Inc.2014-06-06
K133397P-PODP-Pod2014-04-18
K111609BOSTON BANDBoston Brace Intl., Inc.2011-08-22
K111247CRANIAL REMOLDING ORTHOSISOrthotic Care Services, Llp2011-08-15
K103362AOI CRANIAL HELMETAdvanced Orthopro, Inc.2011-04-18

Legacy Summary#

summary

FDA Review#

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