The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Initial Lisi Block.
| Device ID | K153130 |
| 510k Number | K153130 |
| Device Name: | Initial LiSi Block |
| 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 | 2016-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0470130090 | K153130 | 000 |
| D0470129270 | K153130 | 000 |
| 04548161398964 | K153130 | 000 |
| 04548161398957 | K153130 | 000 |
| 04548161398940 | K153130 | 000 |
| 04548161320828 | K153130 | 000 |
| 04548161320811 | K153130 | 000 |
| 04548161320804 | K153130 | 000 |
| 04548161320798 | K153130 | 000 |
| 04548161320781 | K153130 | 000 |
| 04548161320774 | K153130 | 000 |
| 04548161320767 | K153130 | 000 |
| D0470129280 | K153130 | 000 |
| D0470129290 | K153130 | 000 |
| D0470129300 | K153130 | 000 |
| D0470130080 | K153130 | 000 |
| D0470130070 | K153130 | 000 |
| D0470130060 | K153130 | 000 |
| D0470130050 | K153130 | 000 |
| D0470130040 | K153130 | 000 |
| D0470130030 | K153130 | 000 |
| D0470130020 | K153130 | 000 |
| D0470129340 | K153130 | 000 |
| D0470129330 | K153130 | 000 |
| D0470129320 | K153130 | 000 |
| D0470129310 | K153130 | 000 |
| 04548161320750 | K153130 | 000 |