The following data is part of a premarket notification filed by Micro Dental Laboratories with the FDA for Fusicryl.
Device ID | K984467 |
510k Number | K984467 |
Device Name: | FUSICRYL |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | MICRO DENTAL LABORATORIES 6665 AMADOR PLAZA RD., #200 Dublin, CA 94568 |
Contact | Nicolas E Azar |
Correspondent | Nicolas E Azar MICRO DENTAL LABORATORIES 6665 AMADOR PLAZA RD., #200 Dublin, CA 94568 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-16 |
Decision Date | 1999-02-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FUSICRYL 75471627 2511353 Dead/Cancelled |
4T Quattroti S.r.L. 1998-04-21 |