The following data is part of a premarket notification filed by Sckoon Inc. with the FDA for Sckooncup.
| Device ID | K120107 |
| 510k Number | K120107 |
| Device Name: | SCKOONCUP |
| Classification | Cup, Menstrual |
| Applicant | SCKOON INC. 2301 COLLINS AVE #310 Miami Beach, FL 33139 |
| Contact | Mohamed Elgayar |
| Correspondent | Mohamed Elgayar SCKOON INC. 2301 COLLINS AVE #310 Miami Beach, FL 33139 |
| Product Code | HHE |
| CFR Regulation Number | 884.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-13 |
| Decision Date | 2012-09-18 |
| Summary: | summary |