The following data is part of a premarket notification filed by Esco Precision, Inc. with the FDA for Hot Biopsy Forceps.
| Device ID | K905088 |
| 510k Number | K905088 |
| Device Name: | HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | ESCO PRECISION, INC. 21 WILLIAM PENN DR. Stony Brook, NY 11790 |
| Contact | Ted Esser |
| Correspondent | Ted Esser ESCO PRECISION, INC. 21 WILLIAM PENN DR. Stony Brook, NY 11790 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-14 |
| Decision Date | 1991-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405051930 | K905088 | 000 |
| 10653405051923 | K905088 | 000 |
| 10653405051916 | K905088 | 000 |
| 10653405051909 | K905088 | 000 |