MMG BILE BAG
FDA 510(k) clearance K911129 · decided 1991-08-07
Clearance details
- K-number
- K911129
- Device name
- MMG BILE BAG
- Applicant
- Medical Technologies of Georgia
- Decision
- Substantially Equivalent
- Date received
- 1991-03-14
- Decision date
- 1991-08-07
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- EXF
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Decatur, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MERIT DRAINAGE DEPOT (K003078) | Merit Medical Systems, Inc. | 2000-12-11 |
| DRAINAGE BAG (K990428) | Remington Medical, Inc. | 1999-08-12 |
| MANAN D BAG (K980005) | Medical Device Technologies, Inc. | 1998-01-30 |
| MANAN D BAG (K961986) | Manan Medical Products, Inc. | 1997-03-13 |
| MANAN D BAG (K963849) | Manan Medical Products, Inc. | 1996-12-13 |
| NAVARRE 600 ML DRAINAGE BAG (K943663) | Navarre Biomedical , Ltd. | 1994-09-08 |
| URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (K903449) | Uresil Corp. | 1990-09-12 |
| URESIL TRU-CLOSE DRAINAGE BAG (K901844) | Uresil Corp. | 1990-06-01 |
Recalls involving this device
No recalls on record reference this clearance.