The following data is part of a premarket notification filed by Percuvision Llc with the FDA for Directvision Guide System.
| Device ID | K091600 |
| 510k Number | K091600 |
| Device Name: | DIRECTVISION GUIDE SYSTEM |
| Classification | Urethroscope |
| Applicant | PERCUVISION LLC 765 NORTH HAMILTON RD. SUITE 260A Gahanna, OH 43230 |
| Contact | Errol O Singh, M.d. |
| Correspondent | Errol O Singh, M.d. PERCUVISION LLC 765 NORTH HAMILTON RD. SUITE 260A Gahanna, OH 43230 |
| Product Code | FGC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855308006038 | K091600 | 000 |
| 00855308006021 | K091600 | 000 |