The following data is part of a premarket notification filed by Mikro-tek Laboratories with the FDA for Mikro-aquapurator.
| Device ID | K895756 |
| 510k Number | K895756 |
| Device Name: | MIKRO-AQUAPURATOR |
| 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 | 1989-12-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817984011116 | K895756 | 000 |
| 10817984010324 | K895756 | 000 |
| 10817984010317 | K895756 | 000 |
| 10817984010294 | K895756 | 000 |
| 10817984010287 | K895756 | 000 |
| 10817984010270 | K895756 | 000 |
| 10817984010072 | K895756 | 000 |
| 10817984010065 | K895756 | 000 |
| 10817984010058 | K895756 | 000 |
| 10817984010041 | K895756 | 000 |
| 10817984010034 | K895756 | 000 |
| 10817984010027 | K895756 | 000 |
| 10817984010010 | K895756 | 000 |
| 10817984010003 | K895756 | 000 |
| 10817984010331 | K895756 | 000 |
| 10817984010348 | K895756 | 000 |
| 10817984010379 | K895756 | 000 |
| 10817984011109 | K895756 | 000 |
| 10817984011093 | K895756 | 000 |
| 10817984011086 | K895756 | 000 |
| 10817984011048 | K895756 | 000 |
| 10817984011031 | K895756 | 000 |
| 10817984011024 | K895756 | 000 |
| 10817984011017 | K895756 | 000 |
| 10817984011000 | K895756 | 000 |
| 10817984010751 | K895756 | 000 |
| 10817984010744 | K895756 | 000 |
| 10817984010737 | K895756 | 000 |
| 10817984010393 | K895756 | 000 |
| 10817984010386 | K895756 | 000 |
| 10817984010362 | K895756 | 000 |