The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Hot Biopsy Forceps.
| Device ID | K943078 |
| 510k Number | K943078 |
| Device Name: | HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | INTL. MEDICAL, INC. 10061 AMBERWOOD RD. Fort Myers, FL 33913 |
| Contact | Petter H Wetterman |
| Correspondent | Petter H Wetterman INTL. MEDICAL, INC. 10061 AMBERWOOD RD. Fort Myers, FL 33913 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-28 |
| Decision Date | 1994-11-14 |