The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for Gc Fusion.
| Device ID | K041398 |
| 510k Number | K041398 |
| Device Name: | GC FUSION |
| Classification | Material, Impression |
| Applicant | GC AMERICA, INC. 3737 W. 127TH ST. Alsip, IL 60803 |
| Contact | Terry L Joritz |
| Correspondent | Terry L Joritz GC AMERICA, INC. 3737 W. 127TH ST. Alsip, IL 60803 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-26 |
| Decision Date | 2004-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6581370042 | K041398 | 000 |
| D6581377101 | K041398 | 000 |
| D6581377121 | K041398 | 000 |
| D6581377131 | K041398 | 000 |
| D6581377141 | K041398 | 000 |
| D6581377151 | K041398 | 000 |
| D6581377171 | K041398 | 000 |
| D6581377181 | K041398 | 000 |
| D6581377191 | K041398 | 000 |
| D6581378621 | K041398 | 000 |
| D6581378631 | K041398 | 000 |
| D6581378641 | K041398 | 000 |
| D6581378701 | K041398 | 000 |
| D6581379021 | K041398 | 000 |
| D6581379701 | K041398 | 000 |
| D6581500041 | K041398 | 000 |
| D6581500051 | K041398 | 000 |
| 10386040001441 | K041398 | 000 |
| D6581377091 | K041398 | 000 |
| D6581377081 | K041398 | 000 |
| D6581372042 | K041398 | 000 |
| D6581373042 | K041398 | 000 |
| D6581373342 | K041398 | 000 |
| D6581373701 | K041398 | 000 |
| D6581374021 | K041398 | 000 |
| D6581374042 | K041398 | 000 |
| D6581374442 | K041398 | 000 |
| D6581374701 | K041398 | 000 |
| D6581375191 | K041398 | 000 |
| D6581375701 | K041398 | 000 |
| D6581377001 | K041398 | 000 |
| D6581377011 | K041398 | 000 |
| D6581377021 | K041398 | 000 |
| D6581377031 | K041398 | 000 |
| D6581377041 | K041398 | 000 |
| D6581377051 | K041398 | 000 |
| D6581377071 | K041398 | 000 |
| 10386040001458 | K041398 | 000 |
| 10386040001502 | K041398 | 000 |
| 10386040001526 | K041398 | 000 |
| 10386040005753 | K041398 | 000 |
| 10386040005760 | K041398 | 000 |
| 10386040005777 | K041398 | 000 |
| 10386040005784 | K041398 | 000 |
| 10386040005791 | K041398 | 000 |
| 10386040005807 | K041398 | 000 |
| 10386040005814 | K041398 | 000 |
| 10386040005838 | K041398 | 000 |
| 10386040005845 | K041398 | 000 |
| 00386040006098 | K041398 | 000 |
| 10386040006101 | K041398 | 000 |
| 20386040013359 | K041398 | 000 |
| 20386040013366 | K041398 | 000 |
| 10386040013376 | K041398 | 000 |
| 10386040013383 | K041398 | 000 |
| 10386040013390 | K041398 | 000 |
| 10386040013406 | K041398 | 000 |
| 10386040005746 | K041398 | 000 |
| 10386040005739 | K041398 | 000 |
| 10386040001571 | K041398 | 000 |
| 10386040001588 | K041398 | 000 |
| 10386040001595 | K041398 | 000 |
| 10386040001649 | K041398 | 000 |
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| 20386040005170 | K041398 | 000 |
| 20386040005194 | K041398 | 000 |
| 20386040005309 | K041398 | 000 |
| 20386040005361 | K041398 | 000 |
| 20386040005514 | K041398 | 000 |
| 10386040005555 | K041398 | 000 |
| 20386040005569 | K041398 | 000 |
| 20386040005583 | K041398 | 000 |
| 10386040005692 | K041398 | 000 |
| 10386040005708 | K041398 | 000 |
| 10386040005715 | K041398 | 000 |
| 10386040005722 | K041398 | 000 |
| D6581378651 | K041398 | 000 |