The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Reusable Biopsy Forceps Oval Cup, Reusable Biosy Forceps Oval Cup W/needle, Reusable Biopsy Forceps Serrated Cup, Reusar.
| Device ID | K974312 |
| 510k Number | K974312 |
| Device Name: | REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1998-01-21 |