FDA.reportPublic FDA data

DANMAR PRODUCTS, INC.

Matched from indexed company URL: DANMAR PRODUCTS INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18316801831680DANMAR PRODUCTS, INC.1N2026-01-01221 JACKSON INDUSTRIAL DR. ANN ARBOR MI US 48103

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00862948000302Michigan Cranial Reshaping Orthosis - The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.(800)783-1998sales@danmarproducts.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
333741410440095K090341MICHIGAN CRANIAL RESHAPING ORTHOSISMVA2010-01-06
333741484313381K013452DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESISMVA2003-10-31
333741915064904K003630DANMAR PRODUCTS MICHIGAN CRANIAL HELMETMVA2001-05-29
333741500686901
333741558256570

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MVA32010-01-06

PMN#

GUDID#