The following data is part of a premarket notification filed by Sancella, Inc. with the FDA for Medi Guard Dental Bib.
| Device ID | K911944 |
| 510k Number | K911944 |
| Device Name: | MEDI GUARD DENTAL BIB |
| Classification | Drape, Surgical |
| 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-01 |
| Decision Date | 1991-10-04 |