Device Classification Name |
sterilization wrap containers, trays, cassettes & other accessories
|
510(k) Number |
K212068 |
Device Name |
Biotech Dental Kits |
Applicant |
Biotech Dental, SAS |
305 Allées De Craponne |
Salon de Provence,
FR
13300
|
|
Applicant Contact |
Delphine Mercier |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Melissa Burbage |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 07/02/2021 |
Decision Date | 11/08/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|