The following data is part of a premarket notification filed by Coombs Medical Device Consulting with the FDA for Estech Percutaneous Insertion Dilator Kit.
| Device ID | K070749 |
| 510k Number | K070749 |
| Device Name: | ESTECH PERCUTANEOUS INSERTION DILATOR KIT |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | COOMBS MEDICAL DEVICE CONSULTING 1193 SHERMAN STREET Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs COOMBS MEDICAL DEVICE CONSULTING 1193 SHERMAN STREET Alameda, CA 94501 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-19 |
| Decision Date | 2007-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00803622112522 | K070749 | 000 |
| 00803622146947 | K070749 | 000 |