The following data is part of a premarket notification filed by Gabriel Medical, Inc. with the FDA for Infra Vision Bougie Kit, Infra Vision Esophageal Kit.
| Device ID | K960173 |
| 510k Number | K960173 |
| Device Name: | INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT |
| Classification | Bougie, Esophageal, And Gastrointestinal, Gastro-urology |
| Applicant | GABRIEL MEDICAL, INC. ATTN: MARY M. MCNAMARA 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane GABRIEL MEDICAL, INC. ATTN: MARY M. MCNAMARA 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | FAT |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-06-27 |
| Summary: | summary |