The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Resuable Hot Biopsy Forceps.
| Device ID | K972505 |
| 510k Number | K972505 |
| Device Name: | RESUABLE HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Contact | Gretchen Y Cohen |
| Correspondent | Gretchen Y Cohen UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. Mentor, OH 44060 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1997-09-18 |
| Summary: | summary |