The following data is part of a premarket notification filed by Pd International Ab with the FDA for Probe Tip/peri Probe/peri Probe Comp..
Device ID | K936221 |
510k Number | K936221 |
Device Name: | PROBE TIP/PERI PROBE/PERI PROBE COMP. |
Classification | Probe, Periodontic |
Applicant | PD INTERNATIONAL AB Lund, Sweden, SE |
Contact | Annette Mattsson |
Correspondent | Annette Mattsson PD INTERNATIONAL AB Lund, Sweden, SE |
Product Code | EIX |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-27 |
Decision Date | 1994-08-01 |