The following data is part of a premarket notification filed by Scholten Surgical Instruments, Inc. with the FDA for Novatome, Model: Su101-50.
| Device ID | K072051 |
| 510k Number | K072051 |
| Device Name: | NOVATOME, MODEL: SU101-50 |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | SCHOLTEN SURGICAL INSTRUMENTS, INC. 170 COMMERCE ST. # 101 Lodi, CA 95240 |
| Contact | Jim Van Andel |
| Correspondent | Jim Van Andel SCHOLTEN SURGICAL INSTRUMENTS, INC. 170 COMMERCE ST. # 101 Lodi, CA 95240 |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-26 |
| Decision Date | 2007-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866215000064 | K072051 | 000 |
| 00866215000057 | K072051 | 000 |
| 00866215000040 | K072051 | 000 |
| 00866215000033 | K072051 | 000 |
| 00866215000026 | K072051 | 000 |
| 00866215000019 | K072051 | 000 |
| 00866215000002 | K072051 | 000 |