Data / Medical devices / Australia / Mano And Mano Pty Ltd
Mano And Mano Pty Ltd: FDA-registered device maker in Moorabbin Airport Victoria, Australia, 1 510(k) clearance
Mano And Mano Pty Ltd is registered with the FDA (registration 3013414814) in Moorabbin Airport Victoria, Australia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 6, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013414814
- Address
- 11 Duigan Drive, Moorabbin Airport Victoria, Australia, 3194
- Owner or operator
- Mano and Mano Pty Ltd (10052899)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- October 17, 2016
- Registered through
- 2026
- Brand names listed
- BOOM Water Based Lubricant 8 fl oz, Devotion Water Based Lubricant 16 fl oz ( 500ml), Hello Sailor Water Based Lubricant 16 fl oz ( 500ml), Hot Stuff Water Based Lubricant 8 fl oz, Keep Going Water Based Lubricant 8 fl oz, Love & Luster Water Based Lubricant 16 fl oz ( 500ml), Lulu Water Based Lubricant 16 fl oz ( 500ml), Lulu Art series water based lubricant 3 x 8oz bottles and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 6, 2016 | K161585 | Mano and Mano Personal Lubricant | NUC | Substantially Equivalent | Mano and Mano Proprietary Limited | accessdata.fda.gov |
Compare with other makers
Updated September 6, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.