The following data is part of a premarket notification filed by Cpac, Inc. with the FDA for Steri-dent, Steri-sure.
| Device ID | K094026 |
| 510k Number | K094026 |
| Device Name: | STERI-DENT, STERI-SURE |
| Classification | Sterilizer, Dry Heat |
| Applicant | CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester, NY 14481 -0175 |
| Contact | Jeffrey Crane |
| Correspondent | Jeffrey Crane CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester, NY 14481 -0175 |
| Product Code | KMH |
| CFR Regulation Number | 880.6870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-30 |
| Decision Date | 2011-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B234KMHSD301000230 | K094026 | 000 |
| B234KMHSD301000115 | K094026 | 000 |
| B234KMHSD201000230 | K094026 | 000 |
| B234KMHSD201000115 | K094026 | 000 |