510(k) K841626
- Device
- PUNCH
- Applicant
- PLASTAFIL, INC.
- 510(k) number
- K841626
- Product code
- HXG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-27
- Date received
- 1984-04-19
- Regulation
- 888.4540
- Classification name
- Tamp
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1057946
- 3010687973
- 1423507
- 3010041511
- 3010386387
- 9616250
- 3017521423
- 3019878714
- 3004464325
- 9611112
- 1721676
- 3015399803
- 3005739886
- 1020279
- 9612075
- 1649379
- 1221934
- 3009882675
- 1219655
- 1423662
- 3005061536
- 3015451162
- 1720747
- 3010097171
- 3036795921
- 3010763958
- 1043534
- 1000432246
- 1032347
- 3012234585
- 3015967359
- 3014938863
- 9617426
- 3012130008
- 1833920
- 3002719998
- 3015225571
- 1724474
- 3016237080
- 1835998
- 1421879
- 3010123303
- 3016789487
- 8010769
- 3004571672
- 3005031160
- 3007922509
- 3035858921
- 2134285
- 3004153896
- 1721504
- 9610905
- 3011623994
- 2248030
- 9710524
- 9680026
- 1057425
- 3012267976
- 3000270450
- 3009509485
- 3011577940
- 3003418325
- 3015309643
- 3018094310
- 3003526896
- 3015895045
- 3014286836
- 8030607
- 3004774118
- 9616671
- 3007648354
- 3010009693
- 8044098
- 3007539489
- 3008650117
- 3009973336
- 2249529
- 3005596514
- 2936485
- 3006950086
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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