The following data is part of a premarket notification filed by Sancella, Inc. with the FDA for Medi Guard Sheets/underlays.
| Device ID | K911953 |
| 510k Number | K911953 |
| Device Name: | MEDI GUARD SHEETS/UNDERLAYS |
| Classification | Bedding, Disposable, Medical |
| Applicant | SANCELLA, INC. 6-2300 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H 5S2 Canada, CA |
| Contact | Doreen Edey |
| Correspondent | Doreen Edey SANCELLA, INC. 6-2300 BRISTOL CIRCLE OAKVILLE, ONTARIO L6H 5S2 Canada, CA |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-01 |
| Decision Date | 1991-05-28 |