510(k) K003630
- Device
- DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
- Applicant
- DANMAR PRODUCTS, INC.
- 510(k) number
- K003630
- Product code
- MVA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-05-29
- Date received
- 2000-11-24
- 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
- KAREN A LINDNER
- Address
- 221 Jackson Industrial Dr. Ann Arbor MI US 48103 48103
FDA Registration Numbers#
- 3015259854
- 3003895329
- 1721652
- 2030829
- 3001967835
- 3038871395
- 3005021665
- 1000246715
- 1058152
- 1215709
- 1831680
- 1000560772
- 3042028951
- 3003603920
- 2032381
Source Documents#
Other 510(k) Records For Product Code MVA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241957 | Talee, Talee PostOp | Invent Medical USA, LLC | 2024-08-30 |
| K230444 | Talee, Talee PostOp | Invent Medical USA, LLC | 2023-06-22 |
| K223238 | STARband 3D | Orthomerica Products, Inc. | 2023-04-20 |
| K220681 | Talee, Talee PostOP | Invent Medical USA, LLC | 2022-09-22 |
| K203134 | Hanger Cranial Band 3D | Symbion Logistics, LLC | 2022-07-01 |
| K213587 | MyCRO Band | Otto Bock Healthcare LP | 2022-06-09 |
| K193383 | SnugKap | Headstart, Ltd. | 2021-06-07 |
| K201426 | MyCRO Band | Otto Bock Healthcare LP | 2021-03-26 |
| K180568 | KidCap | Eastern Cranial Affiliates, LLC | 2018-10-16 |
| K141842 | STARBAND, STARLIGHT | Orthomerica Products, Inc. | 2014-10-06 |
| K140353 | STARBAND AND STARLIGHT | Orthomerica Products, Inc. | 2014-06-06 |
| K133397 | P-POD | P-Pod | 2014-04-18 |
| K111609 | BOSTON BAND | Boston Brace Intl., Inc. | 2011-08-22 |
| K111247 | CRANIAL REMOLDING ORTHOSIS | Orthotic Care Services, Llp | 2011-08-15 |
| K103362 | AOI CRANIAL HELMET | Advanced Orthopro, Inc. | 2011-04-18 |
Legacy Summary#
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FDA Review#
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