510(k) K960173
- Device
- INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
- Applicant
- GABRIEL MEDICAL, INC.
- 510(k) number
- K960173
- Product code
- FAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-06-27
- Date received
- 1996-01-16
- Regulation
- 876.5365
- Classification name
- Bougie, Esophageal, And Gastrointestinal, Gastro-urology
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY MCNAMARA-CULLINANE
- Address
- Attn: Mary M. Mcnamara 49 Plain St. North Attleboro MA US 02760 02760
FDA Registration Numbers#
- 3023657851
- 3010612620
- 3006750742
- 3013526170
- 2183446
- 3010041511
- 3026671998
- 3011137372
- 3004365956
Source Documents#
Other 510(k) Records For Product Code FAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133439 | PILLING ESOPHAGEAL BOUGIES | Teleflexmedical, Inc. | 2014-06-16 |
| K983220 | STRYKER INFRAVISION ESOPHAGEAL KIT | Stryker Endoscopy | 1999-06-04 |
| K972119 | MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) | Medovations, Inc. | 1998-02-02 |
| K901425 | PYLORIC BALLOON DILATOR | Telemed Systems, Inc. | 1990-06-21 |
| K843186 | ESKA MULTISTAGE ESOPHAGEAL BOUGIE | Dacomed Corp. | 1985-01-18 |
| K842679 | ESOPHAGEAL DILATOR SET | Mill-Rose Laboratory | 1984-10-02 |
| K780471 | GASTRIC LAVAGE KIT | Gaymar Industries, Inc. | 1978-06-02 |
Legacy Summary#
summary
FDA Review#
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