NAVARRE 600 ML DRAINAGE BAG
FDA 510(k) clearance K943663 · decided 1994-09-08
Clearance details
- K-number
- K943663
- Device name
- NAVARRE 600 ML DRAINAGE BAG
- Applicant
- Navarre Biomedical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-28
- Decision date
- 1994-09-08
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- EXF
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, 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 |
| MMG BILE BAG (K911129) | Medical Technologies of Georgia | 1991-08-07 |
| 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.