510(k) K884379
- Device
- MAGLINTE ENTEROCLYSIS CATHETER
- Applicant
- LAFAYETTE PHARMACAL, INC.
- 510(k) number
- K884379
- Product code
- FGD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-28
- Date received
- 1988-10-18
- Regulation
- 876.5980
- Classification name
- Catheter, Retention, Barium Enema With Bag
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT A SHARP
- Address
- 522 N. Earl Ave. Lafayette IN US 47903 47903
FDA Registration Numbers#
- 1417592
- 3010339057
- 3006210673
- 3038190598
- 3010291427
- 3008496560
- 3010547268
- 3005099803
- 3025337868
- 2411512
- 9610849
- 3006536657
- 3016872092
- 3011752740
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FGD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223890 | NAJA Gastrointestinal Catheter | Chess Medical, Inc. | 2023-06-16 |
| K905026 | DUAL FLEX NON-LATEX | Mmi, Inc. | 1991-12-18 |
| K905574 | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF | E-Z-Em, Inc. | 1991-01-24 |
| K904299 | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF | E-Z-Em, Inc. | 1990-11-27 |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | Mac Lee Medical Products | 1987-11-17 |
Legacy Summary#
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FDA Review#
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