The following data is part of a premarket notification filed by Medic Evaluation Devices & Instruments Corp. with the FDA for Racz Epidural Catheter.
| Device ID | K954584 |
| 510k Number | K954584 |
| Device Name: | RACZ EPIDURAL CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | MEDIC EVALUATION DEVICES & INSTRUMENTS CORP. 6 DIVISION ST., P.O. BOX 1128 Gloversville, NY 12078 |
| Contact | Donald R Henderson |
| Correspondent | Donald R Henderson MEDIC EVALUATION DEVICES & INSTRUMENTS CORP. 6 DIVISION ST., 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 | 1995-10-02 |
| Decision Date | 1996-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818788022155 | K954584 | 000 |
| 10818788021110 | K954584 | 000 |
| 10818788021103 | K954584 | 000 |
| 10818788021097 | K954584 | 000 |
| 10818788021073 | K954584 | 000 |
| 10818788021066 | K954584 | 000 |
| 10818788021059 | K954584 | 000 |
| 10818788021042 | K954584 | 000 |
| 10818788021035 | K954584 | 000 |
| 10818788021028 | K954584 | 000 |
| 10818788021011 | K954584 | 000 |
| 10818788021127 | K954584 | 000 |
| 10818788021134 | K954584 | 000 |
| 10818788021141 | K954584 | 000 |
| 00818788022141 | K954584 | 000 |
| 10818788022117 | K954584 | 000 |
| 10818788021721 | K954584 | 000 |
| 10818788021707 | K954584 | 000 |
| 10818788021424 | K954584 | 000 |
| 10818788021417 | K954584 | 000 |
| 10818788021400 | K954584 | 000 |
| 10818788021219 | K954584 | 000 |
| 10818788021165 | K954584 | 000 |
| 10818788021158 | K954584 | 000 |
| 10818788020526 | K954584 | 000 |