The following data is part of a premarket notification filed by Medi-globe Corp. with the FDA for Gip/meid-globe Hot Biopsy Forceps.
| Device ID | K953355 |
| 510k Number | K953355 |
| Device Name: | GIP/MEID-GLOBE HOT BIOPSY FORCEPS |
| Classification | Forceps, Biopsy, Electric |
| Applicant | MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Contact | Gina M Gallegos |
| Correspondent | Gina M Gallegos MEDI-GLOBE CORP. 6202 SOUTH MAPLE AVE. # 131 Tempe, AZ 85283 |
| Product Code | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1996-04-04 |
| Summary: | summary |