510(k) K873955

Device: NAMIC ANGIOGRAPHIC SYRINGE
Applicant: NORTH AMERICAN INSTRUMENT CORP.
510(k) number: K873955
Product code: DXT
Decision: Substantially Equivalent (SESE)
Decision date: 1988-02-05
Date received: 1987-09-28
Regulation: 870.1650
Classification name: Injector And Syringe, Angiographic
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Traditional
Third party reviewed: No
Source: FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact: EAMONN P HOBBS
Address: Glens Falls NY US 12801 12801

FDA Registration Numbers

3010665433
3020298301
2521402
3013820501
1061124
3004727093
1054713
3012044688
3012536737
3006791331
2032098
1018470
3007007790
3003829571
3015009200
3035858922
2243252
3009504230
9610612
3010131137
3016096098
1721676
3033589330
3006950086
3012307300
3003786696
3003561450
3003915875
3007084575
3008692839
3010009632
1000604079
8022210
3004050971
1625425
1043214
3007048453
3013529745
1055236
1058584
3015173212
3003768277
1526863
2936999
1417592
3015276088
1928237
8044099
3008850249
3003542872
1526534
1724474
3001650535
1319639
3007361214
3015183635
3003120897
3009763019
3011334555
3010160527
3012395857
1038185
1720929
2523676
2320762
3034544377
3013764800
3010934635
3011604145
3007138831
2032112
8043817
3016761372
3004605321
3002808086
3003627840
1123137
3012127758
1047843
3031503890
2020394
3011642792
3042190142
1643817
2249018
3019807891
3003898360
1518293
2027111
1721686
9616990
2029275
3004111573
3020460367
3014498725
1060680
3009196578
3002949731
3004080920
2520313
3014615028
3010041511
9610849
1054241
1043729
1526711
3009746061
3015225571
3004068971
9616567
3014246639
3011137372
3015309643
2011171
2022435
3004056159
1721504
3009882464
3004753774
3018094310
2134243
3009051888
3015910259

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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Legacy Summary

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