The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Safesept Transseptal Trocar Guidewire.
| Device ID | K081986 |
| 510k Number | K081986 |
| Device Name: | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE |
| Classification | Trocar |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2008-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00891492002395 | K081986 | 000 |