Device Classification Name |
Purifier, Air, Ultraviolet, Medical
|
510(k) Number |
K200500 |
Device Name |
Molekule Air Pro RX |
Applicant |
Molekule, Inc. |
1301 Folsom St. |
San Francisco,
CA
94103
|
|
Applicant Contact |
Frank Bianco |
Correspondent |
Hyman, Phelps, & McNamara, P.C. |
700 Thirteenth Street N.W., Suite 1200 |
Washington,
DC
20005
|
|
Correspondent Contact |
Adrienne R. Lenz |
Regulation Number | 880.6500
|
Classification Product Code |
|
Date Received | 02/28/2020 |
Decision Date | 04/15/2020 |
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
|
|
|