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 |