The following data is part of a premarket notification filed by Cpac, Inc. with the FDA for Steri-dent, Steri-sure.
| Device ID | K110867 |
| 510k Number | K110867 |
| Device Name: | STERI-DENT, STERI-SURE |
| Classification | Wrap, Sterilization |
| Applicant | CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester, NY 14481 -0175 |
| Contact | Jeffrey S Crane |
| Correspondent | Jeffrey S Crane CPAC, INC. 2364 LEICESTER RD. P.O. BOX 175 Leicester, NY 14481 -0175 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-29 |
| Decision Date | 2011-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B234FRGSSNP400651 | K110867 | 000 |
| B234FRGSSNP400639 | K110867 | 000 |
| B234FRGSSNP400638 | K110867 | 000 |
| B234FRGSSNP400637 | K110867 | 000 |
| B234FRGSSNP400636 | K110867 | 000 |