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#
- 3010667733
- 1423507
- 9617601
- 1720929
- 3034676720
- 1221934
- 3005528784
- 9616250
- 9610905
- 3016237080
- 9611274
- 2132732
- 3036795921
- 1043534
- 3004638600
- 3035858921
- 3002719998
- 3008114965
- 1721504
- 3003637761
- 3011513267
- 3004983210
- 1724474
- 3010197239
- 3010303097
- 3011489618
- 3033536312
- 3007648354
- 8043496
- 1038671
- 9611112
- 3010123256
- 2529846
- 3010039400
- 3012234585
- 8010379
- 1923569
- 1222928
- 2087382
- 3005809810
- 9613910
- 3006982954
- 3003526896
- 1833053
- 3014286836
- 3018094310
- 1057425
- 8010099
- 1834331
- 1020279
- 9610612
- 3010386387
- 3007289746
- 1522875
- 8030607
- 3009599228
- 3005910889
- 3004153896
- 1032347
- 3006639944
- 3011137372
- 3006460162
- 1055890
- 1818910
- 3019455
- 3004571672
- 8010665
- 3015876273
- 1649390
- 3011577940
- 3008650117
- 9680026
- 2248030
- 3009509485
- 3015526568
- 3011623994
- 9710524
- 3010763958
- 1643264
- 1833920
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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