The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Gastrointestinal Sheath Brush.
| Device ID | K834402 |
| 510k Number | K834402 |
| Device Name: | GASTROINTESTINAL SHEATH BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | HOBBS MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-14 |
| Decision Date | 1984-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20874485002750 | K834402 | 000 |
| 20874485002712 | K834402 | 000 |