FDA.reportPublic FDA data

SPECTRUM MEDICAL IMAGING CO

Matched from indexed company URL: Spectrum Medical Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20273272027327SPECTRUM MEDICAL IMAGING CO1Y2026-01-011721 Stewart St Santa Monica CA US 90404
30061264283006126428SPECTRUM MEDICAL INC1Y2026-01-01481 Munn Road, Suite 180 Fort Mill SC US 29715

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
05060434420756Quantum ® - Quantum Pump Frame 2 - Cheltenham+441242650120eusales@spectrummedical.com
05060434420756Quantum ® - Quantum Pump Frame 2 - Cheltenham800 265 2331ussales@spectrummedical.com
05060434420824Quantum - Quantum Pump Frame 3 - Vienna+441242650120eusales@spectrummedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
887281042567990K190282Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ2019-05-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DTQ12019-05-24

PMN#

GUDID#

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