The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Ppd Balloon Dilatation Catheter.
| Device ID | K020379 |
| 510k Number | K020379 |
| Device Name: | PPD BALLOON DILATATION CATHETER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Contact | Michael Carroll |
| Correspondent | Michael Carroll TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. Hudson, MA 01749 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-05 |
| Decision Date | 2002-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813353010127 | K020379 | 000 |
| 00813353010110 | K020379 | 000 |