The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Fujinon Forceps -- Modification.
| Device ID | K922396 |
| 510k Number | K922396 |
| Device Name: | FUJINON FORCEPS -- MODIFICATION |
| Classification | Forceps, Biopsy, Non-electric |
| Applicant | HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Contact | Rob Whalen |
| Correspondent | Rob Whalen HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Product Code | FCL |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1992-12-10 |