The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Pigalileo 4th Generation System.
| Device ID | K080875 |
| 510k Number | K080875 |
| Device Name: | PIGALILEO 4TH GENERATION SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Rishi Sinha |
| Correspondent | Rishi Sinha SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611996099201 | K080875 | 000 |