The following data is part of a premarket notification filed by Gynavations, Inc. with the FDA for Enhance Clitoral Stimulation Aid.
| Device ID | K043480 |
| 510k Number | K043480 |
| Device Name: | ENHANCE CLITORAL STIMULATION AID |
| Classification | Device, Engorgement, Clitoral |
| Applicant | GYNAVATIONS, INC. 665 SALEM STREET Malden, MA 02148 |
| Contact | David Gloth |
| Correspondent | David Gloth GYNAVATIONS, INC. 665 SALEM STREET Malden, MA 02148 |
| Product Code | NBV |
| CFR Regulation Number | 884.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-16 |
| Decision Date | 2005-06-08 |