The following data is part of a premarket notification filed by Cabot Medical Corp. with the FDA for Hysteroscope.
| Device ID | K896917 |
| 510k Number | K896917 |
| Device Name: | HYSTEROSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Contact | Todd Polk |
| Correspondent | Todd Polk CABOT MEDICAL CORP. 2021 CABOT BOULEVARD WEST Langhorne, PA 19047 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-11 |
| Decision Date | 1990-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925002531 | K896917 | 000 |