The following data is part of a premarket notification filed by Gallini Medical Devices, Srl with the FDA for Herniatome Percutaneous Disectomy Device - Cervical, Herniatome Percutaneous Disectomy Device - Lumbar.
| Device ID | K141557 |
| 510k Number | K141557 |
| Device Name: | HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR |
| Classification | Arthroscope |
| Applicant | GALLINI MEDICAL DEVICES, SRL 1531 FELTON ROAD South Euclid, OH 44121 |
| Contact | Arthur S Goddard |
| Correspondent | Arthur S Goddard GALLINI MEDICAL DEVICES, SRL 1531 FELTON ROAD South Euclid, OH 44121 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2014-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033737113844 | K141557 | 000 |