The following data is part of a premarket notification filed by M3 Global Enterprises, Llc with the FDA for Royal Condoms (natural, Black Grape, Coffee, Strawberry, And Chocolate Flavors).
| Device ID | K161195 |
| 510k Number | K161195 |
| Device Name: | Royal Condoms (Natural, Black Grape, Coffee, Strawberry, And Chocolate Flavors) |
| Classification | Condom |
| Applicant | M3 GLOBAL ENTERPRISES, LLC 70 BIRCH ALLEY, SUITE 240 BUILDING B Beavercreek, OH 45440 |
| Contact | Neil Mehta |
| Correspondent | Lara Luzak REGISTRAR CORP 144 RESEARCH DRIVE Hampton, VA 23666 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00646437668996 | K161195 | 000 |
| 00646435669009 | K161195 | 000 |
| 00850012584445 | K161195 | 000 |
| 00850012584155 | K161195 | 000 |
| 00850012584148 | K161195 | 000 |
| 00850012584131 | K161195 | 000 |
| 00850012584124 | K161195 | 000 |
| 00850012584117 | K161195 | 000 |
| 00850012584100 | K161195 | 000 |
| 00850012584018 | K161195 | 000 |
| 00646437668811 | K161195 | 000 |
| 00646437668828 | K161195 | 000 |
| 00646437668835 | K161195 | 000 |
| 00646437668989 | K161195 | 000 |
| 00646437668958 | K161195 | 000 |
| 00646437668910 | K161195 | 000 |
| 00646437668903 | K161195 | 000 |
| 00646437668897 | K161195 | 000 |
| 00646437668880 | K161195 | 000 |
| 00646437668873 | K161195 | 000 |
| 00646437668866 | K161195 | 000 |
| 00646437668859 | K161195 | 000 |
| 00850012584001 | K161195 | 000 |