The following data is part of a premarket notification filed by Covalon Technologies, Inc. with the FDA for Mediclear Preop.
| Device ID | K163556 |
| 510k Number | K163556 |
| Device Name: | MediClear PreOp |
| Classification | Drape, Surgical |
| Applicant | COVALON TECHNOLOGIES, INC. 1660 TECH AVENUE UNIT 5 Mississsauga, CA L4w 5s7 |
| Contact | Kim Crooks |
| Correspondent | Kim Crooks COVALON TECHNOLOGIES, INC. 1660 TECH AVENUE UNIT 5 Mississsauga, CA L4w 5s7 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-12-19 |
| Decision Date | 2017-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10825439016180 | K163556 | 000 |
| 00825439012871 | K163556 | 000 |
| 10825439012809 | K163556 | 000 |
| 00825439013007 | K163556 | 000 |
| 00825439012826 | K163556 | 000 |