The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Transvaginal Endoscopy Set.
| Device ID | K033728 |
| 510k Number | K033728 |
| Device Name: | TRANSVAGINAL ENDOSCOPY SET |
| Classification | Culdoscope (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Contact | Yvonne Fernandez |
| Correspondent | Yvonne Fernandez KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE 5TH FLOOR Culver City, CA 90230 -7600 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-28 |
| Decision Date | 2004-02-27 |
| Summary: | summary |