The following data is part of a premarket notification filed by Molekule, Inc. with the FDA for Molekule Air Pro Rx.
Device ID | K200500 |
510k Number | K200500 |
Device Name: | Molekule Air Pro RX |
Classification | Purifier, Air, Ultraviolet, Medical |
Applicant | Molekule, Inc. 1301 Folsom St. San Francisco, CA 94103 |
Contact | Frank Bianco |
Correspondent | Adrienne R. Lenz Hyman, Phelps, & McNamara, P.C. 700 Thirteenth Street N.W., Suite 1200 Washington, DC 20005 |
Product Code | FRA |
CFR Regulation Number | 880.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-02-28 |
Decision Date | 2020-04-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00818701020308 | K200500 | 000 |