The following data is part of a premarket notification filed by Mikro-tek Laboratories with the FDA for Irri-evacuator.
| Device ID | K895757 |
| 510k Number | K895757 |
| Device Name: | IRRI-EVACUATOR |
| Classification | Catheter, Irrigation |
| Applicant | MIKRO-TEK LABORATORIES 220 SOUTH LORI LN. Bloomington, IN 47401 |
| Contact | Thomas P Clement |
| Correspondent | Thomas P Clement MIKRO-TEK LABORATORIES 220 SOUTH LORI LN. Bloomington, IN 47401 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817984011055 | K895757 | 000 |