The following data is part of a premarket notification filed by Carestream Health,inc. with the FDA for Cs 1200.
| Device ID | K112321 |
| 510k Number | K112321 |
| Device Name: | CS 1200 |
| Classification | Unit, Operative Dental |
| Applicant | CARESTREAM HEALTH,INC. 1765 THE EXCHANGE Atlanta, GA 30339 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer CARESTREAM HEALTH,INC. 1765 THE EXCHANGE Atlanta, GA 30339 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-12 |
| Decision Date | 2011-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192156560070 | K112321 | 000 |
| 60192156559999 | K112321 | 000 |
| 60192155950438 | K112321 | 000 |