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BIOSEAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20270622027062BIOSEAL1N2026-01-01167 WEST ORANGETHORPE AVE. PLACENTIA CA US 92870
30436204143043620414Bioseal1N2026-01-01801 Industrial Blvd Ste 100 Grapevine TX US 76051

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
347421117764780K893814SURGICAL INSTRUMENT KIT, DISPOSABLELRO1989-08-10
3482151117764780K893814SURGICAL INSTRUMENT KIT, DISPOSABLELRO1989-08-10
347421309471349K882712STICK SPONGEEFQ1988-08-03
347421957424290K882708GAUZE SPONGE, X-RAY DETECTABLEGDY1988-08-03
347421205351986K882707GAUZE PACKING, X-RAY DETECTABLEGDY1988-08-03
347421529164951K882696DERMICEL, MONTGOMERY STRAPNAD1988-08-26
347421332126698K882695RUBBER BAND, STERILEECI1988-10-13
347421059067784K882694FIXATION DEVICE, TRACH TUBECBH1988-08-15
347421501682447K180937Graftgun Universal Graft Delivery SystemFMF2018-05-10
347421892256325K170675Graftgun Universal Graft Delivery SystemFMF2017-07-19
347421009175923
347421012738508
347421017764756
347421022957253
347421029497239
347421039635897
347421041148545
347421041358152
347421047712531
347421051634750
347421058258396
347421087974779
347421092509283
347421093089223
347421104164245
347421115779220
347421120009715
347421129840845
347421145750085
347421153210605
347421162685660
347421170545433
347421174186770
347421174366357
347421183332345
347421190092951
347421190982312
347421195416447
347421204075405
347421215692133
347421215873934
347421222354224
347421227562268
347421251145855
347421258158764
347421263414410
347421281367399
347421282242016
347421283070628
347421297604335
347421300548735
347421312972013
347421325966674
347421329893730
347421330176593
347421333666767
347421378888340
347421384811709
347421398737854
347421402945965
347421408145031
347421412850097
347421428600742
347421429339681
347421434308258
347421439969684
347421460833344
347421473076262
347421483006335
347421487588659
347421495686463
347421505764880
347421509758072
347421528123537
347421530245894
347421536346032
347421537341997
347421550720800
347421554175584
347421560438698
347421565217845
347421569137768
347421578254919
347421596899431
347421601712278
347421602529917
347421606015289
347421611082193
347421645566931
347421649055073
347421650269073
347421661425049
347421662794575
347421668924667
347421685550206
347421685973949
347421709471355
347421720848364
347421729486979
347421736327597
347421739743689
347421742113449
347421745030366
347421748408744
347421755924058
347421759133544
347421762675625
347421763083859
347421774826028
347421784529711
347421791580071
347421793614769
347421793873227
347421801211401
347421824248613
347421827955065
347421837973916
347421840916369
347421845626232
347421847445923

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMF22018-05-10
LRO21989-08-10
GDY21988-08-03
ECI11988-10-13
NAD11988-08-26
CBH11988-08-15
EFQ11988-08-03

PMN#

GUDID#

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