The following data is part of a premarket notification filed by Laytech Medical Co. with the FDA for Pediatric Drain Bag.
| Device ID | K896581 |
| 510k Number | K896581 |
| Device Name: | PEDIATRIC DRAIN BAG |
| Classification | Collector, Urine, Pediatric, For Indwelling Catheter |
| Applicant | LAYTECH MEDICAL CO. 816 NICHOLS Arlington Heights, IL 60004 |
| Contact | Catherine S Layton |
| Correspondent | Catherine S Layton LAYTECH MEDICAL CO. 816 NICHOLS Arlington Heights, IL 60004 |
| Product Code | FFH |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-17 |
| Decision Date | 1990-01-31 |