The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Video Endoscope-rigid Modification.
| Device ID | K921294 |
| 510k Number | K921294 |
| Device Name: | VIDEO ENDOSCOPE-RIGID MODIFICATION |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1994-07-20 |