The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Telemed Systems Retrieval Basket.
| Device ID | K974300 |
| 510k Number | K974300 |
| Device Name: | TELEMED SYSTEMS RETRIEVAL BASKET |
| Classification | Endoscopic Grasping/cutting Instrument, Non-powered |
| Applicant | TELEMED SYSTEMS, INC. 19 BRIGHAM ST., UNIT 1 Marlborough, MA 01752 |
| Contact | Samuel D Wade |
| Correspondent | Samuel D Wade TELEMED SYSTEMS, INC. 19 BRIGHAM ST., UNIT 1 Marlborough, MA 01752 |
| Product Code | OCZ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1997-12-19 |