The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Neo-vagina Surgery Set And Accessories.
| Device ID | K071754 |
| 510k Number | K071754 |
| Device Name: | NEO-VAGINA SURGERY SET AND ACCESSORIES |
| Classification | Dilator, Vaginal |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Crystal Dizol |
| Correspondent | Crystal Dizol KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HDX |
| CFR Regulation Number | 884.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-28 |
| Decision Date | 2009-01-07 |
| Summary: | summary |