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SPECTRA MEDICAL DEVICES, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12249603000204727SPECTRA MEDICAL DEVICES, LLC1Y2026-01-01299 Ballardvale St Ste 1 WILMINGTON MA US 01887

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
155691298660587K971645REGANES SPINAL NEEDLE (VARIOUS)MIA1997-08-01
155691608695873K945965ATRAUMATIC PENCIL POINT SPINAL NEEDLEBSP1995-08-02
155691223470358K891226VASCULAR ACCESS PORT CONTINUOUS INFUSION SETFPA1989-05-30
155691375371123K884792VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLESFMI1989-01-30
155691435579951K880181REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAYCAZ1988-02-11
155691570108064K854816EPIDURAL ANESTHESIA NEEDLESBSP1985-12-19
155691421779550K163292Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block CrawfordBSP2017-09-08
155691804111067K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleBSP2016-02-05
155691407552940K142791Spectra Soft Tissue Biopsy NeedlesKNW2015-01-21
155691268355923K103740SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULENGT2011-07-29
155691612871682K091462SPECTRA MEDICAL SAFETY SCAPELGDZ2009-12-15
155691080824440K082674SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGEFMF2008-11-28
155692002024595K082580SPECTRA GUIDEWIRE INTRODUCER NEEDLEDYB2008-12-08
155691842070445K032196NBD DISPOSABLE RF CANNULAEGXI2003-10-09
155691174825291K000117AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLEHEE2000-04-13
155691051749606
155691172485803
155691262577788
155691305089280
155691765623245
155691844418696
155691981479597

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BSP42017-09-08
KNW12015-01-21
NGT12011-07-29
GDZ12009-12-15
DYB12008-12-08
FMF12008-11-28
GXI12003-10-09
HEE12000-04-13
MIA11997-08-01
FPA11989-05-30
FMI11989-01-30
CAZ11988-02-11

NDC#

PMN#

GUDID#

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