The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Contact-micro Colpohysteroscope.
| Device ID | K810569 |
| 510k Number | K810569 |
| Device Name: | CONTACT-MICRO COLPOHYSTEROSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-03 |
| Decision Date | 1981-07-16 |