The following data is part of a premarket notification filed by Buffalo Filter, Llc with the FDA for Laparolight Veress Needle.
| Device ID | K171139 |
| 510k Number | K171139 |
| Device Name: | LaparoLight Veress Needle |
| Classification | Insufflator, Laparoscopic |
| Applicant | Buffalo Filter, LLC 5900 Genesee Street Lancaster, NY 14086 |
| Contact | Kyrylo Shvetsov |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-04-18 |
| Decision Date | 2017-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854061361 | K171139 | 000 |
| 30845854061347 | K171139 | 000 |