The following data is part of a premarket notification filed by Gary A. Gelbfish with the FDA for Gelbfish Endo-vac System.
| Device ID | K970233 |
| 510k Number | K970233 |
| Device Name: | GELBFISH ENDO-VAC SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | GARY A. GELBFISH 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | Robert L Sheridan |
| Correspondent | Robert L Sheridan GARY A. GELBFISH 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-21 |
| Decision Date | 1997-10-08 |
| Summary: | summary |