The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Transendoscopic Sclerotheraphy Needle.
| Device ID | K901437 |
| 510k Number | K901437 |
| Device Name: | TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| 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 | FBK |
| 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 | 1990-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813353010271 | K901437 | 000 |
| 00813353010264 | K901437 | 000 |
| 00813353010257 | K901437 | 000 |
| 00813353010240 | K901437 | 000 |
| 00813353010233 | K901437 | 000 |
| 00813353010226 | K901437 | 000 |
| 00813353010219 | K901437 | 000 |
| 00813353010202 | K901437 | 000 |
| 00813353010196 | K901437 | 000 |