The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Sil-med Waste Fluid Dump Bag.
| Device ID | K891471 |
| 510k Number | K891471 |
| Device Name: | SIL-MED WASTE FLUID DUMP BAG |
| Classification | Chisel (osteotome) |
| Applicant | SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Contact | Joseph R Freeman |
| Correspondent | Joseph R Freeman SIL-MED CORP. 700 WARNER BLVD. Taunton, MA 02780 |
| Product Code | KDG |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-15 |
| Decision Date | 1989-08-15 |