The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Vuecath Endoscopic Spinal System.
| Device ID | K982484 |
| 510k Number | K982484 |
| Device Name: | EBI VUECATH ENDOSCOPIC SPINAL SYSTEM |
| Classification | Arthroscope |
| Applicant | ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Contact | Jonas Wilf |
| Correspondent | Jonas Wilf ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-17 |
| Decision Date | 1998-10-08 |
| Summary: | summary |