The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Dfs Joint Fixator, Model 02800.
| Device ID | K981483 |
| 510k Number | K981483 |
| Device Name: | EBI DFS JOINT FIXATOR, MODEL 02800 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-24 |
| Decision Date | 1998-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868084461 | K981483 | 000 |
| 00887868084430 | K981483 | 000 |
| 00887868084423 | K981483 | 000 |