The following data is part of a premarket notification filed by Genicon, Lc with the FDA for Insufflation Needle- 120mm, Model 900-200.
| Device ID | K993625 |
| 510k Number | K993625 |
| Device Name: | INSUFFLATION NEEDLE- 120MM, MODEL 900-200 |
| Classification | Insufflator, Laparoscopic |
| Applicant | GENICON, LC 573 WATERSCAPE WAY Orlando, FL 32828 |
| Contact | Gary Haberland |
| Correspondent | Gary Haberland GENICON, LC 573 WATERSCAPE WAY Orlando, FL 32828 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-26 |
| Decision Date | 2000-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00877972001904 | K993625 | 000 |
| 00877972001898 | K993625 | 000 |