The following data is part of a premarket notification filed by Hakko Medical Co., Ltd. with the FDA for Biosuc.
| Device ID | K013108 |
| 510k Number | K013108 |
| Device Name: | BIOSUC |
| Classification | Instrument, Biopsy |
| Applicant | HAKKO MEDICAL CO., LTD. 7-9 KAMIMEGURO 1-CHOME Meguro-ku, Tokyo, JP 153 |
| Contact | Mshiro Kitagawa |
| Correspondent | Mshiro Kitagawa HAKKO MEDICAL CO., LTD. 7-9 KAMIMEGURO 1-CHOME Meguro-ku, Tokyo, JP 153 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2002-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04526737120034 | K013108 | 000 |
| 04526737120027 | K013108 | 000 |
| 14526737120017 | K013108 | 000 |
| 04526737120003 | K013108 | 000 |