LaparoVue
Laparoscope, General & Plastic Surgery
Buffalo Filter, LLC
The following data is part of a premarket notification filed by Buffalo Filter, Llc with the FDA for Laparovue.
Pre-market Notification Details
| Device ID | K150569 |
| 510k Number | K150569 |
| Device Name: | LaparoVue |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Buffalo Filter, LLC 5900 Genesee Street Lancaster, NY 14086 |
| Contact | Pamela Netzel |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-03-06 |
| Decision Date | 2015-06-10 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815198012363 | K150569 | 000 |
| 20815198012247 | K150569 | 000 |
Trademark Results [LaparoVue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LAPAROVUE 86347262 4923571 Live/Registered |
Buffalo Filter LLC 2014-07-24 |
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