PEDIATRIC DRAIN BAG
FDA 510(k) clearance K896581 · decided 1990-01-31
Clearance details
- K-number
- K896581
- Device name
- PEDIATRIC DRAIN BAG
- Applicant
- Laytech Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-17
- Decision date
- 1990-01-31
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- FFH
- Device class
- 2
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Arlington Heights, IL, 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 |
|---|---|---|
| PEDIATRIC AND INFANT CATH KITS (K905016) | Davol, Inc. | 1990-12-20 |
| INTECARE PEDIATRIC URINE COLLECTOR (K871789) | Mercury Enterprises, Inc. | 1987-08-10 |
Recalls involving this device
No recalls on record reference this clearance.