The following data is part of a premarket notification filed by Neuro Navigational Corp. with the FDA for Disposable Peel-away Introducer Sheath.
| Device ID | K931973 |
| 510k Number | K931973 |
| Device Name: | DISPOSABLE PEEL-AWAY INTRODUCER SHEATH |
| Classification | Endoscope, Neurological |
| Applicant | NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1993-09-14 |