Device Classification Name |
saliva, artificial
|
510(k) Number |
K231205 |
Device Name |
GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray |
Applicant |
GuruNanda LLC |
6645 Caballero Blvd. |
Buena Park,
CA
90620
|
|
Applicant Contact |
Puneet Nanda |
Correspondent |
GuruNanda LLC |
6645 Caballero Blvd. |
Buena Park,
CA
90620
|
|
Correspondent Contact |
Chetan Patel |
Classification Product Code |
|
Date Received | 04/27/2023 |
Decision Date | 08/22/2023 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|