The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Continuous Flow Hystero-resectoscope.
| Device ID | K922420 |
| 510k Number | K922420 |
| Device Name: | CONTINUOUS FLOW HYSTERO-RESECTOSCOPE |
| Classification | Hysteroscope (and Accessories) |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1994-06-14 |