The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Transervical Endoscope (hysteroscope).
| Device ID | K882761 |
| 510k Number | K882761 |
| Device Name: | TRANSERVICAL ENDOSCOPE (HYSTEROSCOPE) |
| Classification | Hysteroscope (and Accessories) |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | Stephen A Sosnowski |
| Correspondent | Stephen A Sosnowski INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-06 |
| Decision Date | 1988-09-20 |