The following data is part of a premarket notification filed by Epimed International, Inc. with the FDA for Feth-r-kath.
| Device ID | K981329 |
| 510k Number | K981329 |
| Device Name: | FETH-R-KATH |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | EPIMED INTERNATIONAL, INC. P.O. BOX 1128 Gloversville, NY 12078 |
| Contact | Donald Henderson |
| Correspondent | Donald Henderson EPIMED INTERNATIONAL, INC. P.O. BOX 1128 Gloversville, NY 12078 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-13 |
| Decision Date | 1998-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788022261 | K981329 | 000 |
| 10818788021240 | K981329 | 000 |
| 10818788021233 | K981329 | 000 |
| 10818788021226 | K981329 | 000 |
| 10818788021202 | K981329 | 000 |
| 10818788021196 | K981329 | 000 |
| 10818788021189 | K981329 | 000 |
| 10818788021172 | K981329 | 000 |
| 10818788021080 | K981329 | 000 |
| 10818788021257 | K981329 | 000 |
| 10818788021264 | K981329 | 000 |
| 10818788021653 | K981329 | 000 |
| 10818788021646 | K981329 | 000 |
| 10818788021639 | K981329 | 000 |
| 10818788021622 | K981329 | 000 |
| 10818788021615 | K981329 | 000 |
| 10818788021295 | K981329 | 000 |
| 10818788021288 | K981329 | 000 |
| 10818788021271 | K981329 | 000 |
| 10818788020779 | K981329 | 000 |