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 |