The following data is part of a premarket notification filed by Kiltex Corp. with the FDA for Kiltex Probe Cover.
| Device ID | K961029 |
| 510k Number | K961029 |
| Device Name: | KILTEX PROBE COVER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | KILTEX CORP. 2064 KILLIAN RD. Akron, OH 44312 |
| Contact | Timothy J Killian |
| Correspondent | Timothy J Killian KILTEX CORP. 2064 KILLIAN RD. Akron, OH 44312 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-14 |
| Decision Date | 1996-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50748426054010 | K961029 | 000 |
| 00859297006000 | K961029 | 000 |
| 00859297006017 | K961029 | 000 |
| 00859297006024 | K961029 | 000 |
| 00859297006031 | K961029 | 000 |
| 00859297006048 | K961029 | 000 |
| 00859297006055 | K961029 | 000 |
| 00859297006062 | K961029 | 000 |
| 00859297006079 | K961029 | 000 |
| 50748426053945 | K961029 | 000 |
| 00748426053957 | K961029 | 000 |
| 50748426053969 | K961029 | 000 |
| 30748426053767 | K961029 | 000 |
| 50748426054027 | K961029 | 000 |