The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Gastrointestinal Cytology Brush.
| Device ID | K901435 |
| 510k Number | K901435 |
| Device Name: | GASTROINTESTINAL CYTOLOGY BRUSH |
| Classification | Endoscopic Cytology Brush |
| Applicant | TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Contact | John A Chaves |
| Correspondent | John A Chaves TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Product Code | FDX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813353010349 | K901435 | 000 |
| 00813353010332 | K901435 | 000 |
| 00813353010325 | K901435 | 000 |
| 00813353010318 | K901435 | 000 |
| 00813353010301 | K901435 | 000 |
| 00813353010295 | K901435 | 000 |