The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for Hot Biopsy Forceps Feenestrated 230 Cm Oval Cup, Hot Biopsy Forceps Serrated 160 Cm Oval Cup, Hot Biopsy Forceps Serratd.
| Device ID | K992390 |
| 510k Number | K992390 |
| Device Name: | HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD |
| Classification | Forceps, Biopsy, Electric |
| Applicant | TELEMED SYSTEMS, INC. 19 BRIGHAM ST., UNIT 1 Marlborough, MA 01752 |
| Contact | John A Chaves |
| Correspondent | John A Chaves TELEMED SYSTEMS, INC. 19 BRIGHAM ST., UNIT 1 Marlborough, MA 01752 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-19 |
| Decision Date | 1999-12-22 |