The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Initial Lisi Press.
| Device ID | K153136 |
| 510k Number | K153136 |
| Device Name: | Initial LiSi Press |
| Classification | Powder, Porcelain |
| Applicant | GC AMERICA INC. 3737 W. 127TH STREET Alsip, IL 60803 |
| Contact | Mark Heiss |
| Correspondent | Mark Heiss GC AMERICA INC. 3737 W. 127TH STREET Alsip, IL 60803 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-30 |
| Decision Date | 2016-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14548161314985 | K153136 | 000 |
| 14548161315135 | K153136 | 000 |
| 14548161315203 | K153136 | 000 |
| 14548161315319 | K153136 | 000 |
| 14548161315425 | K153136 | 000 |
| 14548161315531 | K153136 | 000 |
| 14548161315548 | K153136 | 000 |
| 14548161315555 | K153136 | 000 |
| 14548161315562 | K153136 | 000 |
| 14548161315579 | K153136 | 000 |
| 14548161315586 | K153136 | 000 |
| 14548161315593 | K153136 | 000 |
| 14548161315609 | K153136 | 000 |
| 14548161315128 | K153136 | 000 |
| 14548161315111 | K153136 | 000 |
| 14548161314992 | K153136 | 000 |
| 14548161315005 | K153136 | 000 |
| 14548161315012 | K153136 | 000 |
| 14548161315029 | K153136 | 000 |
| 14548161315036 | K153136 | 000 |
| 14548161315043 | K153136 | 000 |
| 14548161315050 | K153136 | 000 |
| 14548161315067 | K153136 | 000 |
| 14548161315074 | K153136 | 000 |
| 14548161315081 | K153136 | 000 |
| 14548161315098 | K153136 | 000 |
| 14548161315104 | K153136 | 000 |
| 14548161315616 | K153136 | 000 |
| 14548161315623 | K153136 | 000 |
| 14548161315630 | K153136 | 000 |
| D0470128314 | K153136 | 000 |
| D0470128324 | K153136 | 000 |
| D0470128334 | K153136 | 000 |
| D0470128344 | K153136 | 000 |
| D0470128494 | K153136 | 000 |
| D0470128504 | K153136 | 000 |
| D0470128524 | K153136 | 000 |
| D0470128534 | K153136 | 000 |
| D0470128364 | K153136 | 000 |
| D0470128414 | K153136 | 000 |
| D0470128424 | K153136 | 000 |
| D0470128454 | K153136 | 000 |
| D0470128304 | K153136 | 000 |
| D0470128294 | K153136 | 000 |
| 14548161315647 | K153136 | 000 |
| 14548161315654 | K153136 | 000 |
| 14548161315661 | K153136 | 000 |
| 14548161315678 | K153136 | 000 |
| 14548161315685 | K153136 | 000 |
| 14548161315715 | K153136 | 000 |
| 14548161315753 | K153136 | 000 |
| 14548161315869 | K153136 | 000 |
| D0470128254 | K153136 | 000 |
| D0470128264 | K153136 | 000 |
| D0470128274 | K153136 | 000 |
| D0470128284 | K153136 | 000 |
| D0470128564 | K153136 | 000 |