The following data is part of a premarket notification filed by Hager Worldwide, Inc. with the FDA for Reso-pac Periodontal Dressing.
| Device ID | K050658 |
| 510k Number | K050658 |
| Device Name: | RESO-PAC PERIODONTAL DRESSING |
| Classification | Cement, Dental |
| Applicant | HAGER WORLDWIDE, INC. 2000 M STREET, N.W. 7TH FLOOR Washington, DC 20036 -3307 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli HAGER WORLDWIDE, INC. 2000 M STREET, N.W. 7TH FLOOR Washington, DC 20036 -3307 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-14 |
| Decision Date | 2005-05-27 |
| Summary: | summary |