The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Dideco-shiley Waste Collection Bag.
| Device ID | K872158 |
| 510k Number | K872158 |
| Device Name: | DIDECO-SHILEY WASTE COLLECTION BAG |
| Classification | Apparatus, Autotransfusion |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Ganz Pobuda |
| Correspondent | Ganz Pobuda SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-04 |
| Decision Date | 1987-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033178110830 | K872158 | 000 |
| 38033178110151 | K872158 | 000 |
| 38033178105447 | K872158 | 000 |
| 38033178105430 | K872158 | 000 |