The following data is part of a premarket notification filed by Procell Surgical, Inc. with the FDA for Procell Surgical Sponge-blood Recovery Unit.
| Device ID | K193361 |
| 510k Number | K193361 |
| Device Name: | ProCell Surgical Sponge-Blood Recovery Unit |
| Classification | Apparatus, Autotransfusion |
| Applicant | ProCell Surgical, Inc. 19 Menin Rd Toronto, CA M6c 3j1 |
| Contact | Robert Krensky |
| Correspondent | Sharyn Orton MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-04 |
| Decision Date | 2020-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B890SBRU011 | K193361 | 000 |